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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC NEO METER OPTIUM FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC NEO METER OPTIUM FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 75175-84
Device Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2020
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.
 
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.Visual inspection was performed on returned meter.Inserted batteries on returned meter.Indicator lights did not flash.Meter powered on with button depression.No new issues were observed.Blank screen was not observed.The complaint was not confirmed.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.
 
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Brand Name
NEO METER OPTIUM FREESTYLE
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key11037426
MDR Text Key222360045
Report Number2954323-2020-14003
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K140371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/06/2021
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 Number75175-84
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received05/05/2021
Supplement Dates FDA Received05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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