BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LANCING DEVICE II

    MDR report key: 11889060 · Received May 26, 2021

    Report

    Report Number
    2954323-2021-70408
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    FMK
    UDI-DI
    00357599000000
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME PRODUCT HAS NOT YET 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 A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND LANCING DEVICE, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MFG 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.

    Description of Event or Problem · 1

    A CALLER REPORTED A CUSTOMER STATED THE FIRING MECHANISM ON HIS ADC LANCING DEVICE WAS NOT WORKING AND THEREFORE WAS UNABLE TO CHECK THEIR BLOOD GLUCOSE. AS A RESULT, THE CUSTOMER REPORTED BEING HOSPITALIZED AND RECEIVING THIRD-PARTY TREATMENT. NO FURTHER INFORMATION WAS PROVIDED AS THE CUSTOMER GOT FRUSTRATED AND DISCONNECTED THE CALL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784314 FREESTYLE LANCING DEVICE II LANCING DEVICE FMK ABBOTT DIABETES CARE INC 71582-01 00357599000000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R