BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233821 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48562
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WAS NOTED DURING THE VISUAL INSPECTION. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 116 MG/DL. CUSTOMER WAS GOING TO TAKE A SHOWER AND WAS ATTEMPTING TO SUSPEND THE PUMP WHEN HE RECEIVED A BUTTON ERROR. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715334 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR