BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6039903 · Received October 19, 2016

    Report

    Report Number
    2032227-2016-33030
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST FOLLOWED BY A MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM FUNCTIONAL TESTING INCLUDING A21 ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST DUE TO MOTOR ERROR ALARMS. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, DISPLAY WINDOW, BELT CLIP SLOT AND BATTERY TUBE THREADS. THE INSULIN PUMP ALSO HAD MINOR SCRATCHED DISPLAY WINDOW.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL OF ISSUES WITH THEIR INSULIN PUMP. THE CUSTOMER STATES THE PUMP ALARMED FOR MOTOR ERROR. THE CUSTOMER STATES THEY HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVEL OF 389MG/DL. THE CUSTOMER STATES THEY WERE TREATED AT THE HOSPITAL FOR THE HIGHS. THE CUSTOMER WAS ADVISED THE PUMP WOULD BE REPLACED AND RETURNED FOR ANALYSIS. THE CUSTOMER DECLINED TO FURTHER TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691554 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization