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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 71938-01
Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 08/15/2022
Event Type  Injury  
Event Description
A customer reported being unable to test due to an unresponsive display of the adc device.The customer reported experiencing a loss of consciousness and was provided glucose gel by a family member for treatment.No further information was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
At this time product has not yet been returned.An 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.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.Touchscreen test was performed and touchscreen responded properly.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported being unable to test due to an unresponsive display of the adc device.The customer reported experiencing a loss of consciousness and was provided glucose gel by a family member for treatment.No further information was reported.There was no report of death or permanent injury 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
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key15438279
MDR Text Key300048336
Report Number2954323-2022-34377
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160030
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 10/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71938-01
Device Catalogue Number71938-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received09/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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