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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC PRECISION CARD QID METER; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC PRECISION CARD QID METER; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
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, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
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
The returned meter was investigated with retained test strips.Meter did not power on with button depression or test strip insertion.The meter was de-cased and corrosion was observed due to liquid ingress on the pcba.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.Note: the device manufacturer date for the reported meter serial number is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.
 
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.
 
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Brand Name
PRECISION CARD QID METER
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key11900207
MDR Text Key256167152
Report Number2954323-2021-70609
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
PMA/PMN Number
K971812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2021
Date Manufacturer Received07/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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