BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2874295 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-91390
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS RECEIVED STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE DISPLACEMENT TEST FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT TEST AND THE TEST FAILED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP. 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 59 YR