BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2991775 · Received March 6, 2013

    Report

    Report Number
    2032227-2013-00903
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 10, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARMS DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE DISPLACEMENT, PRIME, BASIC OCCLUSION, OCCLUSION OR NO DELIVERY TESTS DUE TO THE MOTOR ERROR ALARMS DURING REWIND. THE INSULIN PUMP ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DEHYDRATION. THE REPORTED BLOOD GLUCOSE READING WAS 577 MG/DL. THE CUSTOMER STATED THAT HE COULDN'T HOLD ANYTHING DOWN. THE CUSTOMER STATED THAT HE WAS ALSO TOLD HE HAD AN INFECTION. THE CUSTOMER'S DAUGHTER HAD PREVIOUSLY CALLED TO REPORT A MOTOR ERROR ALARM. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96261 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization