BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4130286 · Received September 30, 2014

    Report

    Report Number
    2032227-2014-08894
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP UNABLE TO CHARGE DUE TO DAMAGED PIN NUMBER FIVE. UNABLE TO PERFORM THE FUNCTIONAL TEST DUE TO CHARGE ANOMALY. INSULIN PUMP RECEIVED WITH MOISTURE DAMAGE IN ALL PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR TRANSMITTER HAD BEEN EXPOSED TO MOISTURE. CUSTOMER STATED THAT THE DEVICE HAD BEEN EXPOSED TO MOISTURE WHEN THEY WERE SWIMMING AND THE DEVICE WAS PULLED OFF OF THEIR BODY. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 104 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607082 MINILINK TRANSMITTER CGM MDS MMT-7703NA A000324069

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR