BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4871472 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-68945
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, THE INSULIN PUMP GOT WET AS SHE WAS AT THE LAKE AND NOW THE DEVICE WAS NOT FUNCTIONING. SHE REMOVED THE BATTERY FROM THE DEVICE, REINSERTED IT, AND ANOMALY PERSISTED. CUSTOMER HAD HEARD A LOUD SQUALLING NOISE ON THE DEVICE, IT ALSO STARTED TO COUNT DOWN AND THEN IT BEEP LOUDLY. TROUBLESHOOTING FOR BLANK DISPLAY WAS PERFORMED. CUSTOMER DIDN'T RECALL HER BLOOD GLUCOSE LEVEL AT THE TIME OF ANOMALY BUT HAS BEEN HIGH. DAMAGE WAS LOCATED ON THE TOP RIGHT CORNER OF THE LCD. CUSTOMER WAS UNSURE HOW DAMAGE OCCURRED. THE DEVICE WASN'T DROPPED OR BUMPED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. SHE DECLINED RETURNING THE DEVICE FOR ANALYSIS. SHE ALSO STATED SHE HAD LOST THE BATTERY CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414662 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR