BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3932976 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86873
    Event Type
    Malfunction
    Date Received
    July 14, 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
    GA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING HIS INSULIN PUMP HAS A BLANK SCREEN. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 130 MG/DL. HE SAID THAT THE DEVICE ALARMED LOW BATTERY, AND AFTER CHANGING THE BATTERY THE DISPLAY WENT BLANK. CUSTOMER WENT AND BOUGHT NEW BATTERIES, BUT THE DISPLAY IS STILL BLANK. THERE IS NO PHYSICAL DAMAGE TO THE DEVICE. IT WAS NOT DROPPED OR BUMPED. THERE WAS NO EXPOSURE TO MOISTURE. CUSTOMER USES ENERGIZER AAA ALKALINE BATTERIES. THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED, AND NEITHER IS THE BATTERY COMPARTMENT. CUSTOMER WAS ADVISED TO WAIT TEN MINUTES AND INSERT THE NEW BATTERY. THE DISPLAY RETURNED. THE DEVICE PASSED THE SELF TEST. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. A REPLACEMENT BATTERY CAP WAS SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410736 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR