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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; 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 03/24/2022
Event Type  Injury  
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.Dhrs (device history record) 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.The date of event is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported that the touchscreen display of the adc device was unresponsive and was therefore unable to monitor glucose.The customer became hypoglycemic and lost consciousness, requiring treatment of glucagon injection administered by third-party.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported that the touchscreen display of the adc device was unresponsive and was therefore unable to monitor glucose.The customer became hypoglycemic and lost consciousness, requiring treatment of glucagon injection administered by third-party.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection was performed and damage was observed due to use related issues.Reader log was downloaded and readings were observed in the reader.This complaint is therefore not confirmed due to use.
 
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Brand Name
FREESTYLE LIBRE 14 DAY
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 Key13943388
MDR Text Key288167283
Report Number2954323-2022-10351
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
Reporter Country CodeFR
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 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
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 Received06/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2018
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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