BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3830674 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84922
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    CUSTOMER REPORTED SHE WAS HOSPITALIZED FOR TWO DAYS DUE TO HIGH BLOOD GLUCOSE. SHE STATED THAT HER BLOOD GLUCOSE LEVEL STARTED AT 139MG/DL ON THE DAY OF THE EVENT AND BY NIGHTTIME IT HAD GONE UP TO 588MG/DL. AT THE TIME OF THE HOSPITALIZATION HER BLOOD GLUCOSE WAS 750MG/DL. CUSTOMER COMPLAINED ABOUT HAVING EXPERIENCED DIABETIC KETOACIDOSIS. CUSTOMER TREATED WITH MANUAL INJECTION. CURRENT BLOOD GLUCOSE READING IS 339MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP IS FUNCTIONING CORRECTLY AND SHE STATED THAT THERE MIGHT HAVE BEEN A FAULTY INFUSION SET THAT COULD HAVE CONTRIBUTED TO THE BLOOD GLUCOSE GOING HIGH. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308302 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization