BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4203556 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-31669
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER INSULIN PUMP SHUT OFF AND ALARMED FAILED BATTERY TEST. CUSTOMER REPLACED THE BATTER AND NOW THE DEVICE HAS A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE IS 233 MG/DL. CUSTOMER USES DURACELL BATTERIES. THE DEVICE HAS NOT BEEN BUMPED OR EXPOSED TO MOISTURE RECENTLY. THE BATTERY COMPARTMENT AND CONTACTS ARE NOT DAMAGED OR CORRODED. CUSTOMER INSERTED A NEW BATTERY BUT THE DISPLAY DID NOT RETURN. CUSTOMER REMOVED THE BATTERY FOR TEN MINUTES, CLEANED THE CONTACTS, REINSERTED THE NEW BATTERY, AND THE DISPLAY RETURNED. THE DEVICE PASSED THE SELF TEST. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK IF THE ISSUE RECURS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682658 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR