BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181556 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-92125
    Date Received
    October 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAS A BUTTON ERROR ON THEIR INSULIN PUMP AND BUTTONS ARE TAKING A LONG TIME TO RESPOND. PATIENT'S BLOOD GLUCOSE LEVEL IS 291 MG/DL. TROUBLE SHOOTING IS CONDUCTED. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661554 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR