FreeStyle Libre 2 Plus · Flash Glucose Monitoring System
Abbott Diabetes Care Inc · Device Alarm System
- Manufacturer contact zip ext
- -700
- Manufacturer contact state
- CA
- Manufacturer link flag
- Y
- Manufacturer contact address 1
- 1360 South Loop Road
- Manufacturer contact pcity
- +1(510)3
- Event type
- Malfunction
- Report number
- 2954323-2026-308548
- Product problem flag
- Y
- Date received
- 20260831
- PMA pmn number
- K223435
- Date of event
- 20251001
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 94502
- Reporter occupation code
- 003
- Manufacturer contact plocal
- +1(510)384-5975
- Noe summarized
- 1
- Manufacturer contact l name
- Pieplow
- Reporter country code
- SW
- Date added
- 20260831
- Manufacturer contact f name
- Melissa
- Device date of manufacturer
- 20250413
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260831
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260830
- Initial report to FDA
- No
- Manufacturer contact city
- Alameda
- MDR report key
- 50515037
- Date manufacturer received
- 20251001
- Report source code
- Manufacturer report
- Adverse event flag
- N
- Single use flag
- Y
- Manufacturer contact postal code
- 94502-7001
- Type of report
- Initial submission
- Source type
- Consumer
- Device
- Device sequence number
- 16439
- Serviced by 3rd party flag
- N
- Date received
- 20260831
- Brand name
- FreeStyle Libre 2 Plus
- Generic name
- Flash Glucose Monitoring System
- Manufacturer d name
- Abbott Diabetes Care Inc
- Manufacturer d address 1
- 1360 South Loop Road
- Manufacturer d city
- Alameda
- Manufacturer d state
- CA
- Manufacturer d zip code
- 94502
- Manufacturer d zip code ext
- -700
- Manufacturer d country
- US
- Manufacturer d postal code
- 94502-7001
- Device operator
- LAY USER/PATIENT
- Model number
- 78747-01
- Device availability
- No
- Device report product code
- QBJ
- Device evaluated by manufacturer
- Y
- Combination product flag
- N
- UDI di
- 05021791006717
- UDI public
- (01)05021791006717(17)2026-09-30(10)KTP012067
- Harmonized identifiers (openFDA)
- Device name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1355
- Device class
- 2
- Product problems
- Device Alarm System
- Patient
- Patient sequence number
- 1
- Date received
- 20260831
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions
- MDR text
- MDR text key
- 16116983193
- Text type code
- Additional Manufacturer Narrative
- Patient sequence number
- 0
- Text
At this time, product has not yet been returned. An investigation has been performed for the reported complaint information.The Device History Records (DHRs) for the product were reviewed and the DHRs showed the product passed all tests prior to release.The investigation included a review of the complaint information. The information provided in the complaint was insufficient to conduct a comprehensive investigation. The lack of the full device configuration details restricts the ability to identify potential causes of the customer's reported issue. Based on the investigation findings, no software malfunction or product deficiency was identified. It is not possible to determine the probable cause of this event. There are mitigations in place to reduce and prevent issues such as disconnected, faulty or damaged components or misuse of the device. All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design. Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency. If a product defect/ deficiency is identified, a Risk Evaluation is completed and compared to the Risk Management report, to ensure the risk profile has not changed. Additionally, as a part of Abbott¿s Post-Market Surveillance Process, all Risk Evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product Risk Management reports. These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.If the product is returned, a physical investigation will be performed and a follow-up report submitted.This complaint was reviewed and is being submitted as it has been reassessed as reportable as the result of retrospective review associated with a CAPA. All pertinent information available to Abbott Diabetes Care has been submitted.
- MDR text key
- 15616983192
- Text type code
- Description of Event or Problem
- Patient sequence number
- 0
- Text
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.