BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3251048 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96137
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BROKEN OFF END CAP, PROTRUDED/LOOSE DRIVE SUPPORT DISK, AND MISSING END CAP STICKER. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN END CAP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DROPPED AND THE DRIVE SUPPORT CAP CAME OFF. THE CUSTOMER STATED THAT AFTER THE INCIDENT HER BLOOD GLUCOSE WENT HIGH. THE BLOOD GLUCOSE READING WAS 500MG/DL WHEN SHE WOKE UP AND DID TAKE A CORRECTIVE BOLUS BECAUSE SHE WANTS TO EAT SOME EGGS. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352033 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR