BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831177 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84973
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CALLER STATED THAT HER SON RECEIVED A HIGH BLOOD GLUCOSE READING WHICH LOWERED AFTER ADMINISTERING INSULIN. CALLER STATED THAT PATIENT NOTICED HIS CANNULA WAS BENT AND WENT TO THE HOSPITAL FOR DIABETIC KETOACIDOSIS. PATIENT HAD A BLOOD GLUCOSE LEVEL OF 400 MG/DL AND WAS EXPERIENCING VOMITING, NAUSEA, AND COULD BARELY MOVE. PATIENT'S HEALTH CARE PROVIDER VISITED HIM WHILE HE WAS HOSPITALIZED. PATIENT WAS KEPT IN THE INTENSIVE CARE UNIT FOR TWO DAYS AND RELEASED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308211 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization