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

Model Number	98814-65
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	11/09/2021
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 and precision strips were reviewed, and the dhrs showed the precision xtra meter and precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed within specification.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A caller reported a high reading issue with the adc blood glucose meter.The customer obtained unspecified high reading, but subsequently experienced a loss of consciousness and was unresponsive.The customer was taken to the hospital and healthcare meter results of 72 mg/dl and 79 mg/dl were obtained as compared to adc meter result of 172 mg/dl.The customer was diagnosed with hypoglycemia, and provided unspecified treatment.There was no report of death or permanent injury associated with this event.The results of adc meter against healthcare meter, when plotted on a parkes error grid fall into the "c" zone, showing the difference in values to be clinically significant.
Additional Manufacturer Narrative
The reported meter has been returned and investigated with retained test strips.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button and test strips.Control solution testing has been performed and all results were within range specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A caller reported a high reading issue with the adc blood glucose meter.The customer obtained unspecified high reading, but subsequently experienced a loss of consciousness and was unresponsive.The customer was taken to the hospital and healthcare meter results of 72 mg/dl and 79 mg/dl were obtained as compared to adc meter result of 172 mg/dl.The customer was diagnosed with hypoglcyemia, and provided unspecified treatment.There was no report of death or permanent injury associated with this event.The results of adc meter against healthcare meter, when plotted on a parkes error grid fall into the "c" zone, showing the difference in values to be clinically significant.

• 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12903724
• Report Number: 2954323-2021-93877
• Device Sequence Number: 4946622
• Product Code: NBW
• UDI-Device Identifier: 00093815998778
• UDI-Public: 00093815998778
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 04/04/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: 98814-65
• Device Catalogue Number: 99877
• Device Lot Number: 4500184519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male