BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4760766 · Received May 8, 2015

    Report

    Report Number
    3004209178-2015-54469
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    January 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED THAT THE INSULIN PUMP ALARMED WITH NO DELIVERY. CUSTOMER STATED HE REMOVED THE INFUSION SET FROM INSERTION SITE, MANUALLY PRIMED A COUPLE OF UNITS AND GOT INSULIN TO COME OUT OF THE TUBING. CUSTOMER THEN CHANGED THE SITE AND STILL RECEIVED NO DELIVERY. HE THEN CHANGED INSULIN, RESERVOIR AND INFUSION SET AND RECEIVED 12 UNITS OF INSULIN, EVEN THOUGH THE NO DELIVERY ALARM OCCURRED. THE CUSTOMER DECLINED TO TROUBLESHOOT. CUSTOMER WAS ADVISED THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303838 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR