MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREEDOM METER FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	1001-02
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter contacted abbott diabetes care, alleging the meter will not turn on.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
To date, product has not been returned for further investigation.The useful life of freestyle freedom meter is 5 years.As the manufacturing date of this product is 2016, it has been in distribution beyond its useful life at the time of the complaint.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.No further investigation activities are being performed at this time.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
The reporter contacted abbott diabetes care, alleging the meter will not turn on.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The returned meter was investigated with retained test strips and a known-good retained battery.Visual inspection was performed on returned meter.No new issues were observed.Meter powered on with button depression and test strip insertion.Blank screen was not observed.The complaint was not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREEDOM METER FREESTYLE
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18318508
• Report Number: 2954323-2023-53832
• Device Sequence Number: 20591889
• Product Code: NBW
• UDI-Device Identifier: 00699073110046
• UDI-Public: 00699073110046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1001-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White