MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC PRECISION XTRA METER; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	98814-65
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and distribution of this product line has been discontinued and the manufacturing date of this product shows it is beyond its useful life.Since the product exceeded its useful life, it is determined to have met specification from manufacture through its intended lifespan.No design, manufacturing, or labeling mitigations are required/possible due to the manufacturing and distribution of this product line being discontinued.Such products have had significant time in the field to provide the feedback on failure modes and associated mitigations applicable to that product which are considered and integrated into the mitigations for similar future product.To date, product has not been returned for further investigation.The useful life of the freestyle precision xtra meters will perform in accordance with specifications for a period of no more than 4 years from the original date of purchase.As the manufacturing date of this product is before 2010, 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.Therefore, no further investigation activities are required.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.

• Brand Name: PRECISION XTRA METER
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 20861512
• Report Number: 2954323-2024-47664
• Device Sequence Number: 15076976
• Product Code: NBW
• Combination Product (Y/N): N
• PMA/510(K) Number: K040814
• 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
• Report Date (Section B): 12/05/2024

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: 98814-65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown