BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4014234 · Received August 18, 2014

    Report

    Report Number
    3004209178-2014-94211
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED FAILED BATTERY TEST DUE TO FAULTY BATTERY TUBE. INSULIN PUMP FUNCTIONED PROPERLY AFTER UNPLUGGING AND PLUGGING THE BATTERY TUBE CONNECTOR INTO INTERFACE BOARD. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP AND BATTERY TUBE THREADS. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW.

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP ALARMED FAILED BATTER TEST. CUSTOMER'S BLOOD GLUCOSE WAS 8.2 MMOL/L. CUSTOMER TRIED FIVE DIFFERENT BRAND NEW BATTERIES, BUT THE DEVICE ALARMED FAILED BATTERY TEST. THE BATTERY CAP AND COMPARTMENT ARE NOT DAMAGED. CUSTOMER CLEANED THE CAP AND CONTACTS WITH ALCOHOL AND INSERTED A NEW BATTERY. THE DEVICE ALARMED AGAIN. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492150 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1