BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE SENSOR KIT - 14 DAY

    MDR report key: 17070656 · Received June 5, 2023

    Report

    Report Number
    MW5118163
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 19, 2023
    Report Date
    May 19, 2023
    Manufacturer
    ABBOTT DIABETES CARE LIMITED
    Product Code
    PZE
    UDI-DI
    57599000101
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE IS MISSING FROM 1 SENSOR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON JUNE 15TH 2023 FOR REPORT NUMBER MW5118163 TO UPDATE PROCODE TO PZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093497 FREESTYLE LIBRE SENSOR KIT - 14 DAY SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED PZE ABBOTT DIABETES CARE LIMITED 57599000101
    1988298 FREESTYLE LIBRE SENSOR KIT - 14 DAY SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED PZE ABBOTT DIABETES CARE LIMITED 57599000101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male