BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982042 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89110
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, MISSING END CAP STICKER AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM RANDOMLY ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AT 162 MG/DL. THE CUSTOMER ALSO STATED THAT SHE HAD A MRI DONE AN HOUR PRIOR TO THE MOTOR ERROR ALARMED BUT STATED THAT SHE HAD REMOVED THE PUMP AND PLACED IN ANOTHER ROOM BEFORE TAKING THE MRI. THE INSULIN PUMP WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456564 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR