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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 Problem Material Twisted/Bent (2981)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 04/12/2023
Event Type  Injury  
Event Description
A bent sensor tip was reported with the adc device and customer experienced pain and bleeding and was unable to obtain readings.The customer removed the sensor and self-presented to a hospital where a reading of 48 mg/dl was obtained on an unspecified device and unspecified treatment was provided.No further details were reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been returned and investigation is pending.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Applicator (b)(6) has been returned and investigated.Visually inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was fired correctly.The applicator was opened to inspect the sharp and no issues were observed.Sensor pack (b)(6) has been returned and investigated.Visually inspection has been performed on the sensor pack and no issues were observed.Lid was not completely peeled off.Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the sensor and no issues were observed.The sensor plug was fully seated.Inspected the plug assembly.Visual inspection was performed and cracked sensor neck was observed.Therefore, the issue is not confirmed to use due to incorrect assembly method.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A bent sensor tip was reported with the adc device and customer experienced pain and bleeding and was unable to obtain readings.The customer removed the sensor and self-presented to a hospital where a reading of 48 mg/dl was obtained on an unspecified device and unspecified treatment was provided.No further details were reported.There was no report of death or permanent impairment 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 Key16913497
MDR Text Key315028013
Report Number2954323-2023-18571
Device Sequence Number1
Product Code QLG
UDI-Device Identifier00357599800000
UDI-Public00357599800000
Combination Product (y/n)N
Reporter Country CodeUS
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 06/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/31/2023
Device Model Number71992-01
Device Catalogue Number71992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2023
Date Manufacturer Received05/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2023
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 Age54 YR
Patient SexFemale
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