BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3200566 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-95260
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. 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.

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP RECEIVED WITH CRACK ON RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND PROCESS. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 5.4MMOL/L. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS PROTRUDED. IT WAS MENTIONED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300110 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWP

    Patients

    Seq Age Sex Outcome Treatment
    1