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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 71940-01
Device Problem Low Readings (2460)
Patient Problem Hyperglycemia (1905)
Event Date 08/24/2016
Event Type  Injury  
Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded. A follow-up report will be filed if product is returned or additional information is obtained. The date of event is unknown. The date entered is based on the report of "4 years ago". The device mfg date is unknown. The date entered 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 low readings issue was reported with the freestyle libre sensor. Customer reported that four years ago, she received low sensor scans and being hospitalized. No symptoms were reported, but in the hospital, customer was treated with glucose based on the sensor scan results received. Post-treatment of glucose, a reading of 350 mg/dl was obtained on the hcp meter compared to a sensor scan result of 60 mg/dl, and customer was administered insulin for treatment. No further details were provided. There was no report of death or permanent injury associated with this event.

 
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Brand NameFREESTYLE LIBRE 14 DAY
Type of DeviceFLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
tara williamson
1360 south loop road
alameda, CA 94502-7001
5108644472
MDR Report Key10475037
MDR Text Key205069363
Report Number2954323-2020-05879
Device Sequence Number1
Product Code PZE
Combination Product (Y/N)N
PMA/PMN NumberP160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number71940-01
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/24/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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