BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4173757 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-37780
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 8, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM NOTED DURING BASIC OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO MOISTURE DAMAGE ON FSR. CORRODED MOTOR HOME SWITCH NOTED DURING VISUAL INSPECTION. NO PHYSICAL DAMAGE NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A MOTOR ERROR ALARM DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE WAS 264 MG/DL. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655951 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR