BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2970612 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91199
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THAT THE INSULIN PUMP IS NOT ALARMING WHEN SHE IS NOT GETTING A BOLUS, AND SHE WENT INTO DIABETES KETOACIDOSIS OVER (B)(6). A FIXED PRIME TEST WAS CONDUCTED OVER THE PHONE AND THE INSULIN PUMP ALARMED. THE CALLER STATED THAT HER BLOOD GLUCOSE WENT UP THE NIGHT BEFORE, BUT SHE TREATED HER BLOOD GLUCOSE WITH 7.45 UNITS THROUGH THE INSULIN PUMP AND ALSO A MANUAL OF 15.0 UNITS. THE CUSTOMER FELT THAT THE DEVICE SHOULD HAVE ALARMED WHEN SHE WAS NOT GETTING INSULIN LATE IN THE EVENING AND HER BLOOD GLUCOSE WENT UP TO 407MG/DL. THE CALLER MENTIONED THAT THE CANNULA WAS KINKED/BENT. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING AS SHE WAS AT WORK AT TIME OF CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74410 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 48 YR