BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103094 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26405
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 28, 2012
    Report Date
    June 19, 2012
    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

    (B)(4). THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE FUNCTIONAL TEST INCLUDING THE DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS PACKED AWAY IN A BOX BY PACKERS DURING A HOME RENOVATION AND NEEDED ANOTHER INSULIN PUMP LOANED TO HIM. THE BLOOD GLUCOSE READING WAS 124 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582651 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR