BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780710 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57396
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A SIGNAL TOO LOW ALARM, UNEXPECTED RESTART ALARM AND A PROGRAM ALARM ANOMALY. CUSTOMER'S BLOOD GLUCOSE WAS 207 MG/DL. TROUBLESHOOTING FOUND THE CORRECT BOLUS AMOUNT WAS RECORDED IN THE BOLUS HISTORY. THE INSULIN PUMP ALSO PASSED A SELF-TEST. THE CUSTOMER ALSO CALLED BACK TO REPORT A BLANK DISPLAY ON THEIR INSULIN PUMP. CUSTOMER REQUESTED A REPLACEMENT INSULIN PUMP. THE CUSTOMER WILL NOT RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326262 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR