BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3041695 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92426
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 500MG/DL. THE CALLER STATED THAT HER FATHER FELL AND WAS ADMITTED TO THE HOSPITAL. THEN HE WAS RELEASED, AND WHEN HE GOT HOME HE WAS THROWING UP AND WAS NOT FEELING WELL. THE CUSTOMER WAS TAKEN BACK TO THE FACILITY, AND THE DAUGHTER BELIEVES HIS HIGH BLOOD GLUCOSE MAY HAVE TO DO WITH THE FACT THAT HER FATHER WAS NOT WEARING HIS INSULIN PUMP SINCE HE FELL AND GOT ADMITTED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. AFTER RECEIVING THE TUBING CLAMP THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144052 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization