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

Model Number 70725-01

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

To date, product has not been returned for further investigation.The useful life of freestyle mini meter is 5 years.As the manufacturing date of this product is 2006, 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.

• Brand Name: MINI METER FREESTYLE
• Type of Device: 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: 15631783
• MDR Text Key: 302014518
• Report Number: 2954323-2022-38628
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• PMA/PMN Number: K000582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 70725-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1