BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4813472 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61768
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 EXPERIENCED LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 45 MG/DL. CUSTOMER TREATED THEIR BLOOD GLUCOSE WITH FOOD. THE CUSTOMER ALSO REPORTED A NO DELIVERY ALARM OCCURRING. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT DURING A FIXED PRIME, BUT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 77 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355772 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 69 YR