BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2842267 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-90873
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTON DUE TO CORRODED ACT TRACE. UNIT WAS RECEIVED WITH MISSING END CAP STICKER. UNABLE TO VERIFY FOR TIME ANOMALY DUE TO ACT BUTTON WAS NOT RESPONDING. NO FROZEN SCREEN OR DISPLAY ANOMALY NOTED.

    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 HAD A FROZEN DISPLAY. THE CUSTOMER STATED THAT NO ALARMS OCCURRED DURING OR AFTER THE TIME THAT THE BUTTONS WERE NOT RESPONDING. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING WAS 101MG/DL. INSTRUCTED THE CUSTOMER TO REMOVE THE BATTERY FOR FIVE MINUTES AND TO INSERT A NEW BATTERY, BUT THE INSULIN PUMP CONTINUED HAVING A FROZEN DISPLAY WITH NO ADVANCEMENT OF THE TIME. ADVISED THE CUSTOMER 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
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR