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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); Unable to Obtain Readings (1516); Material Twisted/Bent (2981)
Patient Problem Hypoglycemia (1912)
Event Date 07/11/2022
Event Type  Injury  
Manufacturer Narrative
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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.
 
Event Description
A caller reported that the inserter needle of the adc device was bent and therefore customer was unable to apply sensor.As a result, the customer was unable to monitor glucose and was seen by a healthcare professional who administered unspecified treatment for hypoglycemia.The caller was unable to provide details of treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits 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 caller reported that the inserter needle of the adc device was bent and therefore customer was unable to apply sensor.As a result, the customer was unable to monitor glucose and was seen by a healthcare professional who administered unspecified treatment for hypoglycemia.The caller was unable to provide details of treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor and applicator and no damage was observed.The applicator has not been fired, and the sharp was observed to be loose through the sensor plug.Visual inspection was performed on the sensor pack and damage to the transition features and a misaligned guide rib was observed.The lid of the sensor applicator packaging was not completely peeled off.An extended investigation has also been performed.Visual inspection concluded that a misalignment within the sensor pack assembly prevented the sensor pack¿s platform from lowering completely and caused the user to assemble the sensor patch incorrectly which led to the reported issue.This indicates that the process of assembling the pack platform with the pack container during manufacturing assembly had caused the damage resulting in the misalignment of the sensor container guide ribs and platform alignment and orientation (a&o) features.Therefore, this issue is confirmed due to a manufacturing issue.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A caller reported that the inserter needle of the adc device was bent and therefore customer was unable to apply sensor.As a result, the customer was unable to monitor glucose and was seen by a healthcare professional who administered unspecified treatment for hypoglycemia.The caller was unable to provide details of treatment.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 Key15090118
MDR Text Key296457336
Report Number2954323-2022-25352
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 10/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2022
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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