BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 6177537 · Received December 15, 2016

    Report

    Report Number
    2032227-2016-49944
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    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'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP KEPT ALARMING FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 135 MG/DL. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828274 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR