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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 Problem Failure to Power Up (1476)
Patient Problems Vertigo (2134); Discomfort (2330); Loss of consciousness (2418)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an 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
A customer reported a battery issue with their adc blood glucose meter, stating that it would not turn on with test strip insertion or button press.The customer further reported that they were in hypoglycemia when they were unable to test, and experiencing symptoms of vertigo and discomfort, and subsequently losing consciousness.Emergency services were called, and the customer was administered glucose injection "for 3 days", and "fast and slow insulin" by an hcp for treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has 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, the case will be re-opened, and a physical investigation will be performed.
 
Event Description
A customer reported a battery issue with their adc blood glucose meter, stating that it would not turn on with test strip insertion or button press.The customer further reported that they were in hypoglycemia when they were unable to test, and experiencing symptoms of vertigo and discomfort, and subsequently losing consciousness.Emergency services were called, and the customer was administered glucose injection "for 3 days", and "fast and slow insulin" by an hcp for treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The reported reader has been returned and investigated.Visual inspection performed on the returned reader and no issues or signs of misuse were observed.The reader did not power on with button depression after charging.The reader did not power on with strip insertion.The reader did not power on with insertion of usb cable.Masterm utility software opened and sent command to obtain reader response, no power surge message observed.No damage observed to the usb port.The reader was de-cased and internal visual inspection was performed, observed corrosion caused by liquid ingress.Unable to set time and date and unable to confirm uom (units of measurement).This complaint is not confirmed due to a use issue.No malfunction or product deficiency was identified.
 
Event Description
A customer reported a battery issue with their adc blood glucose meter, stating that it would not turn on with test strip insertion or button press.The customer further reported that they were in hypoglycemia when they were unable to test, and experiencing symptoms of vertigo and discomfort, and subsequently losing consciousness.Emergency services were called, and the customer was administered glucose injection "for 3 days", and "fast and slow insulin" by an hcp for treatment.There was no report of death or permanent impairment associated with this event.
 
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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
MDR Report Key9215348
MDR Text Key163053136
Report Number2954323-2019-08148
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,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
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 Returned to Manufacturer10/25/2019
Date Manufacturer Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight85
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