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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 71992-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Chills (2191); Loss of consciousness (2418); Diaphoresis (2452)
Event Date 05/09/2022
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.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 receiving a ¿replace sensor¿ error message while wearing the adc device and as a result, the customer was unable to obtain glucose readings.The customer experienced cold sweat, passed out (loss of consciousness), and was unable to self-treat.The customer¿s husband administered glucagon injection, biscuits, milk, and ¿oral glucup 15¿ as treatment and no further information was provided.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported receiving a ¿replace sensor¿ error message while wearing the adc device and as a result, the customer was unable to obtain glucose readings.The customer experienced cold sweat, passed out (loss of consciousness), and was unable to self-treat.The customer¿s husband administered glucagon injection, biscuits, milk, and ¿oral glucup 15¿ as treatment and no further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the returned sensor patch.Data was extracted from the returned sensor patch using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21) due to a temporary drop in the source voltage.Visual inspection was performed on the sensor plug and no failure modes were observed.The returned sensor was sent for further investigation and de-cased.Visual inspection was performed on the pcba (printed circuit board assembly) and no issues were observed.An extended investigation has also been performed on the returned sensor.Visual inspection was performed on the returned sensor puck and no issues were observed.The battery was measured, and the results were within specification.Therefore, this issue is confirmed to brownout reset.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 Key14402676
MDR Text Key291701054
Report Number2954323-2022-15563
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSP
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 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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