BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2933844 · Received January 29, 2013

    Report

    Report Number
    2032227-2013-00396
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. NO OTHER ALARMS WERE NOTED. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME OR EXCESSIVE NO DELIVERY TESTS DUE TO THE MOTOR ERROR ALARMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM DURING NORMAL USE. THE CALLER STATED THAT THE INSULIN PUMP WAS WORN DURING A CAT SCAN PRIOR TO ALARMING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CALLER ALSO REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO A STROKE, AND HAS BEEN EXPERIENCING HIGHER THAN NORMAL BLOOD GLUCOSE LEVELS DUE TO THE MEDICATION. THE CALLER STATED THAT THE CUSTOMER WAS BEING TREATED FOR THE BLOOD GLUCOSE READING OF 277 MG/DL. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38550 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization