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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC MINI METER FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC MINI METER FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 70725-01
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2022
Event Type  malfunction  
Manufacturer Narrative
Unless further information is obtained, this issue is considered closed.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
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.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.All pertinent information available to abbott diabetes care has been submitted.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
 
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Brand Name
MINI METER 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 Key16085228
MDR Text Key308258998
Report Number2954323-2023-00110
Device Sequence Number1
Product Code LFR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K000582
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number70725-01
Was Device Available for Evaluation? No
Date Manufacturer Received01/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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