BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4052593 · Received September 2, 2014

    Report

    Report Number
    2032227-2014-15598
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP WAS NOT WORKING PROPERLY. CUSTOMER STATED THE DEVICE ALARMED BUTTON ERROR. CUSTOMER CHANGED THE BATTERY AND NOTHING WAS BEING DISPLAYED ON THE DEVICE. CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. CUSTOMER REPORTED SHE WALKING ONE DAY AND THE DEVICE GOT A LITTLE WET ON 08/01/2014 BUT NOT SUBMERGED, AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER DECLINED TO TROUBLESHOOT FOR BLANK DISPLAY AND UNEXPECTED RESTART. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532761 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR