BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4110754 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27946
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 454 MG/DL. THE CUSTOMER'S WIFE STATED THAT HE HAD FORGOTTEN TO BOLUS. THE CALLER INQUIRED ABOUT AN OPEN CIRCLE; EXPLAINED THAT THIS WAS THE TEMPORARY BASAL FUNCTION. SHE STATED THAT SHE WAS UNSURE WHETHER THE ISSUE WAS THE INSULIN PUMP, BUT SHE NOTED THAT THEY HAD CHANGED THE INFUSION SET AND WOULD CALL BACK IF NECESSARY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590326 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR