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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71953-01
Device Problems Display Difficult to Read (1181); Unable to Obtain Readings (1516)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 11/23/2021
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.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported observing black dots on the display of the freestyle libre 2 reader.As a result, the customer was unable to view glucose readings and fainted, requiring treatment of juice by daughter.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported observing black dots on the display of the freestyle libre 2 reader.As a result, the customer was unable to view glucose readings and fainted, requiring treatment of juice by daughter.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.A visual inspection was performed and a white screen was observed on the returned reader.The reader was sent for further investigation and de-cased.A visual investigation was performed on the pcba (printed circuit board assembly) and liquid contamination was observed.Therefore, this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
 
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Brand Name
FREESTYLE LIBRE 2
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 Key12938236
MDR Text Key281826855
Report Number2954323-2021-94570
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K193371
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 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
Patient Weight89 KG
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