BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984034 · Received February 28, 2013

    Report

    Report Number
    2032227-2013-00890
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE SELF TEST, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. UNABLE TO TEST THE OPERATING CURRENTS AND OFF NO POWER ALARM DUE TO MOTOR ERROR ALARMS. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNABLE TO VERIFY ERROR ALARM IN ALARM HISTORY SCREEN DUE TO MOTOR ERROR ALARMS.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 700 MG/DL. CUSTOMER STATED THAT SHE HAD DIZZINESS, NAUSEA, RAPID HEAR BEAT. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP IS FLUSH ON CUSTOMER'S INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86121 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization