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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC VISION METER PAPILLON FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC VISION METER PAPILLON FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 70914-70
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
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.
 
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.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.The complaint was not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
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Brand Name
VISION METER PAPILLON FREESTYLE
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 Key16077308
MDR Text Key307308207
Report Number2954323-2022-47700
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K092602
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 03/31/2023
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
Device Operator Lay User/Patient
Device Model Number70914-70
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/30/2022
Supplement Dates Manufacturer Received03/30/2023
Supplement Dates FDA Received03/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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