BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY CHARGER MLINK

    MDR report key: 4021876 · Received August 19, 2014

    Report

    Report Number
    2032227-2014-09688
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CHARGE. PROBLEM ISOLATED TO BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGER DID NOT WORK AND THERE WAS AN INSERTION SITE ISSUE. THE BLOOD GLUCOSE READING WAS 94 MG/DL. THE ISSUE WAS NOT RESOLVED WITH A NEW BATTERY. THE CUSTOMER WAS USING THE PROPER METHODOLOGY FOR SITE INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497810 BATTERY CHARGER MLINK CGM MDS MEDTRONIC MINIMED MMT-7705NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR