BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133434 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94052
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE AS A RESULT OF A CORRODED KEYPAD TRACE. UNABLE TO CONFIRM BUTTON ERROR ALARMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE BLOOD GLUCOSE READING WAS 300MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER MENTIONED BEING HOSPITALIZED AND NOT SURE IF IT WAS DIABETES RELATED OR NOT. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236013 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization