BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4823053 · Received June 6, 2015

    Report

    Report Number
    2032227-2015-18137
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC MINIMED
    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

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. THE CUSTOMER, ABOUT A MONTH AGO, FELL IN THE WATER AND GOT RIGHT OUT. THE INSULIN PUMP WAS EXPOSED TO A X-RAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. SHE WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366809 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR