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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71525-01
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
The product has been requested back for investigation.A follow- up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A pharmacist reported that a freestyle libre reader began to smoke when charging.The caller also reported that the reader had a " strong smell of burning." no further details were provided by the caller.There was no report of death, serious injury, or mistreatment associated with this event.
 
Manufacturer Narrative
The reported reader was returned and investigated and no new issues were observed.Reader powers on when the start button is pressed.The reader powered on and advanced to the home screen successfully.The battery charged successfully when a charging cable was inserted.There are no signs of smoke or burning.The event log was downloaded successfully.Reader was de-cases and visual inspection of the pcb (printed circuit board) did not observe any signs of burning or explosion.The complaint is not confirmed.
 
Event Description
A pharmacist reported that a freestyle libre reader began to smoke when charging.The caller also reported that the reader had a " strong smell of burning." no further details were provided by the caller.There was no report of death, serious injury, or mistreatment associated with this event.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7443614
MDR Text Key106010269
Report Number2954323-2018-02993
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71525-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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