BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933281 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87022
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    CUSTOMER CALLED IN ASKING FOR HELP CHANGING THE SETTINGS ON HER INSULIN PUMP. HE SAID THAT LAST NIGHT HIS BLOOD GLUCOSE DROPPED TO 20 MG/DL AND HE BLACKED OUT. CUSTOMER STATED THAT HE IS GOING THROUGH DIALYSIS AND THAT WAS WHY HIS BLOOD GLUCOSE DROPPED SO LOW. HE HAS DIALYSIS SEVEN DAYS A WEEK, TWELVE HOURS A DAY, AND HE HAS NOTICED CHANGES. SOMETIMES INSULIN IS CHANGED FOR HIM. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 190 MG/DL. HE STATED THAT THE DEVICE HAS NOTHING TO DO WITH HIS CHANGING BLOOD GLUCOSE LEVELS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409776 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 58 YR