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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); Malaise (2359); Shaking/Tremors (2515)
Event Date 06/05/2022
Event Type  Injury  
Event Description
A complaint was received regarding the error message, "scan again in 10 minutes" for 2 hours or more while wearing the adc device.As a result, on (b)(6) 2022, the customer experienced tremors, felt tired, not feeling their legs, and could not stand and were provided oral glucose by a non-hcp for the treatment of hypoglycemia no further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.A tripped trend review was completed for the reported complaint and fs libre 2 sensors, and a trend was investigated where a probable root cause was related to an insertion issue.However without a valid sensor number or product return, the root cause of the particular issue associated with this complaint is unknown and cannot be further determined.Clinical data was reviewed and confirmed that freestyle libre 2 sensors continue to be safe, effective, and perform as intended in the field.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.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
 
Event Description
A complaint was received regarding the error message, "scan again in 10 minutes" for 2 hours or more while wearing the adc device.As a result, on (b)(6) 2022, the customer experienced tremors, felt tired, not feeling their legs, and could not stand and were provided oral glucose by a non-hcp for the treatment of hypoglycemia no further information was provided.There was no report of death or permanent injury associated with this event.
 
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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 Key14691278
MDR Text Key294018103
Report Number2954323-2022-19372
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeIT
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 09/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2022
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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