BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 16519135 · Received March 9, 2023

    Report

    Report Number
    2954323-2023-09632
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 20, 2023
    Report Date
    April 13, 2023
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED READER (B)(6) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED READER WAS PERFORMED AND NO ISSUES WERE OBSERVED. PERFORMED BUILT-IN READER TEST AND THE RESULTS WERE SATISFACTORY. AN ERROR MESSAGE WAS NOT OBSERVED DURING INVESTIGATION. NO MALFUNCTION OR PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. THEREFORE, THIS ISSUE IS NOT CONFIRMED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 RECORD) FOR THE LIBRE READER WERE REVIEWED, AND THE DHRS SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72111-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71953-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AND ERROR MESSAGE,¿ ERROR CODE 9,¿ ON THE DISPLAY WHEN TESTING ON THE ADC DEVICE. AS THE CUSTOMER COULD NOT MONITOR THEIR BLOOD GLUCOSE, THE CUSTOMER REPORTED EXPERIENCING CRAMPING, SEIZURE, AND LOSS OF CONSCIOUSNESS. AS A RESULT, AN AMBULANCE WAS CALLED, AND CUSTOMER WAS ADMINISTERED GLUCOSE ORALLY BY THE EMERGENCY DOCTOR. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AND ERROR MESSAGE,¿ ERROR CODE 9,¿ ON THE DISPLAY WHEN TESTING ON THE ADC DEVICE. AS THE CUSTOMER COULD NOT MONITOR THEIR BLOOD GLUCOSE, THE CUSTOMER REPORTED EXPERIENCING CRAMPING, SEIZURE, AND LOSS OF CONSCIOUSNESS. AS A RESULT, AN AMBULANCE WAS CALLED, AND CUSTOMER WAS ADMINISTERED GLUCOSE ORALLY BY THE EMERGENCY DOCTOR. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790258 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention