BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2802015 · Received October 23, 2012

    Report

    Report Number
    2032227-2012-07526
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 THAT HE WAS IN THE HOSPITAL DUE TO A BYPASS SURGERY, AND WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING WAS 303 MG/DL. THE CUSTOMER ONLY WANTED TO CHECK THE BASAL RATES, AND DECLINED ANY TROUBLESHOOTING. THE CUSTOMER STATED THAT HIS WIFE CHANGED THE INFUSION SET, AND KNOWS THAT IT'S NOT OCCLUDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization