BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984437 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-89985
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS STATES THAT THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. ALSO RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A BUTTON ERROR ALARM ON THE INSULIN PUMP, WHICH OCCURRED WHILE TRYING TO DELIVER BOLUS. CUSTOMER STATES AFTER ALARM KEYPAD BECAME UNRESPONSIVE. CURRENT BLOOD GLUCOSE LEVEL IS 148 MG/DL. ADVISED CUSTOMER INSULIN PUMP WILL BE REPLACED AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461190 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR