BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 17190115 · Received June 23, 2023

    Report

    Report Number
    2954323-2023-26803
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 6, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MFG 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.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. NO PRODUCT HAS BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT 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.

    Description of Event or Problem · 0

    AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH HUAWEI P30 PRO (VOG-L29) PHONE WITH ANDROID OPERATING SYSTEM VERSION 10. CUSTOMER RECEIVED A "SCAN ERROR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, "SWEATING", "BLURRED VISION", AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "G MG GLUCOSE" BY A HEALTHCARE PROFESSIONAL (HCP) FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH HUAWEI P30 PRO (VOG-L29) PHONE WITH ANDROID OPERATING SYSTEM VERSION 10. CUSTOMER RECEIVED A "SCAN ERROR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, "SWEATING", "BLURRED VISION", AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "G MG GLUCOSE" BY A HEALTHCARE PROFESSIONAL (HCP) FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866432 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention