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

Model Number	99837-65
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Run on Battery (1466)
Health Effect - Clinical Codes	Hyperglycemia (1905); Muscle Weakness/Atrophy (1967); Dizziness (2194)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the precision xtra meter were reviewed, and the dhrs showed the precision xtra meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported a low battery icon with the adc blood glucose meter, and that due to this he was unable to obtain blood glucose results.The customer experienced weakness, dizziness, and blurred vision, and went to the hospital where he was diagnosed with hyperglycemia and provided unspecified treatment.Additionally, customer reported he was diagnosed with foot infection due to poorly controlled diabetes, and required amputation of a toe.There is no indication that the reported product issue would have caused or contributed to the long-term mismanagement of diabetes, resulting in the required amputation.During troubleshooting, the reported product issue was resolved with battery replacement.There was no report of death or unanticipated permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 12275506
• Report Number: 2954323-2021-78595
• Device Sequence Number: 4494801
• Product Code: NBW
• UDI-Device Identifier: 00093815998372
• UDI-Public: 00093815998372
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 99837-65
• Device Catalogue Number: 99837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 79