BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4419678 · Received January 14, 2015

    Report

    Report Number
    3004209178-2015-84409
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    December 23, 2014
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: PUMP RECEIVED WITH SEVERELY CRACKED AND BLEEDING LCD GLASS. UNABLE TO PERFORM IDLE CURRENT, RUN CURRENT, SELF TEST, OFF NO POWER, A21 ERROR, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME/ A33 AND NO DELIVERY TEST DUE TO LCD DAMAGED. ALSO RECEIVED WITH SEVERELY SCRATCHED DISPLAY WINDOW, CASE DAMAGED, BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT DAMAGE TO THE INSULIN PUMP. IT WAS REPORTED THAT THE CUSTOMER WAS IN A MOTORCYCLE ACCIDENT AND LANDED ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE READING WAS 125 MG/DL. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32041 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR