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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 Difficult to Insert (1316); Failure to Fire (2610)
Patient Problems Headache (1880); Hypoglycemia (1912); Nausea (1970)
Event Date 11/19/2021
Event Type  Injury  
Event Description
A customer reported not receiving a replacement adc freestyle libre 2 sensor, which was issued as customer reported the sensor became stuck in applicator and did not apply.On (b)(6) 2021, as a result, the customer experienced a headache and nausea, and the customer self-presented to a health center where a glucose test result of 42 mg/dl was obtained on the healthcare meter.The customer was provided, presumed intravenous glucose, by a healthcare professional for the treatment of hypoglycemia.A follow-up blood glucose test result of 80 mg/dl was then obtained.No further information was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kits were reviewed and the dhrs showed the 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.
 
Manufacturer Narrative
Code 4756 appropriate term/code not available was used in h6 (component code), as the complaint was confirmed to manufacturing issue.The reported sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor and applicator; no damages were observed.The applicator had not been fired, and sheath was locked.The sensor was removed from the applicator and loose sharp was observed through the sensor plug.A visual inspection was performed on sensor pack and mis-aligned guide ribs were observed.The sensor plug was not properly seated upon visual inspection.An extended investigation was also performed on the returned sensor and components.Visually inspected the sensor pack and observed damage to the sensor packs sheath unlocking tabs.The observed damage can prevent the platform from lowering fully which prevents the plug assembly from transferring and seating correctly.An unseated plug will cause poor signal transfer from plug assembly to the sensor puck electronics.For any sensors that have been activated this will cause dq (data quality) errors resulting in a replace sensor message.This type of damage is possible if the platform is misaligned when the part is picked up for assembly.The mis-aligned guide ribs are a secondary issue that was most likely caused by the customer trying to assemble the faulty product.Therefore, this has been confirmed to be a manufacturing issue.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported not receiving a replacement adc freestyle libre 2 sensor, which was issued as customer reported the sensor became stuck in applicator and did not apply.On (b)(6) 2021, as a result, the customer experienced a headache and nausea, and the customer self-presented to a health center where a glucose test result of 42 mg/dl was obtained on the healthcare meter.The customer was provided, presumed intravenous glucose, by a healthcare professional for the treatment of hypoglycemia.A follow-up blood glucose test result of 80 mg/dl was then obtained.No further information was reported.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 Key12926833
MDR Text Key281732952
Report Number2954323-2021-94457
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 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2022
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient SexFemale
Patient Weight76 KG
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