BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3123020 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93819
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HE MAY HAVE A PROBLEM WITH THE DRIVE SUPPORT CAP. CUSTOMER HAS BEEN RECEIVING NO DELIVERY ALARMS. CUSTOMER'S BLOOD GLUCOSE READING IS 284 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. CUSTOMER HAS DAMAGE TO THE BATTERY COMPARTMENT. THE DRIVE SUPPORT CAP IS LOOSE. ADVISED THAT THE INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223615 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR