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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 Fire (1245)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2017
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
Customer reported that their freestyle reader does not charge and they saw smoke coming from the usb port of the reader.Customer also reported that there was a burnt smell.There was no report of death or serious injury related to this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A dhr (device history review) for the freestyle libre reader was reviewed and the dhr showed the libre reader passed all tests prior to release.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer reported that their freestyle reader does not charge and they saw smoke coming from the usb port of the reader.Customer also reported that there was a burnt smell.There was no report of death or serious injury related to 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 Key7155398
MDR Text Key96212721
Report Number2954323-2017-09217
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 consumer
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
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? No
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2015
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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