BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841750 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02633
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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

    INSULIN PUMP ALARMED BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACE. A CRACKED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER INSULIN PUMP WAS FROZEN BUT NOW IT SHOWS BUTTON ERROR. THE BLOOD GLUCOSE READING IS 213 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER STATED SHE WAS PLAYING SOCCER AND THE INSULIN PUMP WAS AGAINST HER SKIN. CUSTOMER WAS SWEATING. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319080 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR