BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2915831 · Received January 15, 2013

    Report

    Report Number
    2032227-2013-00111
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME AND DISPLACEMENT TEST. HOWEVER, THE INSULIN PUMP WAS STUCK IN MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. ERROR ALARM CONFIRMED IN THE HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING NORMAL USE. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS NOT BEEN EXPOSED TO HIGH MAGNETIC FIELDS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22860 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR