BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 17069688 · Received June 6, 2023

    Report

    Report Number
    2954323-2023-23641
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 7, 2023
    Report Date
    June 6, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    00357599800000
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR, NO ISSUES WERE OBSERVED ON SENSOR PATCH. SENSOR PLUG WAS PROPERLY SEATED AND NO PHYSICAL DAMAGE OBSERVED ON SENSOR PATCH. INSERTION FAILURES (EVENT LOG 2) WAS OBSERVED. WATERMARK WAS NOT OBSERVED AT THE BASE OF THE TAIL. NO FAILURE MODES WERE OBSERVED UPON VISUAL INSPECTION OF THE PLUG ASSEMBLY. LID WAS COMPLETELY PEELED OFF. INSPECTED THE PLATFORM AND NO ISSUES WERE OBSERVED. ISSUE IS NOT CONFIRMED TO TAIL NOT PROPERLY INSERTED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (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.

    Description of Event or Problem · 0

    A WEB FORM COMPLAINT WAS RECEIVED IN WHICH IT WAS REPORTED A CUSTOMER RECEIVED A CHECK SENSOR ERROR MESSAGE ON THE ADC DEVICE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED SWEATING, SHAKING AND ¿COULD NOT THINK AND STAND BUT STILL CONSCIOUS¿, REQUIRING THIRD PARTY ADMINISTRATION OF BAQSIMI 3MG PER NASAL SPRAY FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188593 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 00357599800000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention