BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930833 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86871
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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 STATING THAT HIS INSULIN PUMP IS ALARMING BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 180 MG/DL. CUSTOMER SAID HE WAS WEARING HIS DEVICE IN HIS WAISTBAND AND WHILE HE WAS SWEATING. CUSTOMER MENTIONED DURING THE CALL THAT HE REMOVED THE KEY STICKER FROM THE DEVICE AND IT STARTED TO WORK AGAIN. HE ALSO STATED THAT THE DEVICE HAS A LITTLE CRACK WHERE THE LCD SCREEN IS. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE OF IT AND REVERT TO A BACK UP PLAN UNTIL THE REPLACEMENT ARRIVES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408706 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR