BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982311 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06186
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    UNIT RECEIVED INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS ANOMALY NOTED. PUMP RECEIVED WITH SCRATCHED LCD WINDOW. UNIT RECEIVED WITH CRACKED CASE DISPLAY WINDOW CORNER. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP. UNIT RECEIVED WITH CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE NUMBERS ON THE DISPLAY SCREEN OF THE INSULIN PUMP WERE RAMPING ON THEIR OWN. BLOOD GLUCOSE LEVEL WAS 162 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456585 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS A000207835

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR