BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3884501 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03123
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND ALL REGISTERED PROPERLY IN THE DAILY HISTORY AND ALSO MATCHED PROPERLY WITH THE UNITS LEFT ON THE STATUS SCREEN. NO BOLUS ANOMALY OR HISTORY ANOMALY WAS NOTED. THE INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT HE HAS BEEN EXPERIENCING LOW BGS FOR THE PAST TWO MONTHS, AND FEELS THAT IT'S THE PUMP. THE PATIENTS BG WAS 43 MG/DL, AND WAS TREATED WITH FOOD. TROUBLESHOOTING WAS PERFORMED, AND THE PUMP WAS PROGRAMMED CORRECTLY. NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. THE RESERVOIR VOLUME WAS ACCURATE. THE PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. ADVISED THAT THE PUMP SEEMED TO BE FUNCTIONING PROPERLY, BUT THE PATIENT WAS NOT COMFORTABLE WITH IT. ADVISED THAT THE PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361352 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR