BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984065 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91431
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ANOMALY. THE INSULIN PUMP RECEIVED WITH STRIPPED BATTERY CAP COIN SLOT.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING WAS 212MG/DL. THE CALLER STATED THAT DRIVE SUPPORT CAP WAS FLUSH. THE CUSTOMER STATED THAT THE DEVICE WAS EXPOSED TO AN MRI. THE CUSTOMER WAS IN THE HOSPITAL FOR NON DIABETES RELATED ISSUES. 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
    86463 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR