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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC PRECISION XTRA; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC PRECISION XTRA; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 98814-65
Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)
Patient Problem Loss of consciousness (2418)
Event Date 11/02/2023
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.An extended investigation has been conducted, which involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation did not identify any indication that the product did not meet specification.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced a loss of consciousness.Customer was unable to self-treat and received unspecified hcp treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
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.Damage was observed on the battery cover due to user error, which led to poor connection between the battery and pcba (printed circuit board assembly).Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced a loss of consciousness.Customer was unable to self-treat and received unspecified hcp treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
PRECISION XTRA
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 Key18161001
MDR Text Key328416359
Report Number2954323-2023-50490
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K040814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number98814-65
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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