BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUM

    MDR report key: 4233417 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48802
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    CUSTOMER REPORTED THAT THE SENSOR GLUCOSE READING WAS 70 MG/DL OR LESS AND HER BLOOD GLUCOSE WAS 98 MG/DL AND ALSO ANOTHER TIME THE SENSOR READING WAS 70 AND THE BLOOD GLUCOSE VALUE WAS 118 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND. CUSTOMER DECLINED TO TROUBLESHOOT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712611 INSULIN INFUSION PUM INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR