BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4031824 · Received August 22, 2014

    Report

    Report Number
    2032227-2014-10596
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 THE CUSTOMER WAS ASSISTED BY PARAMEDICS BECAUSE CUSTOMER HAD A SEIZURE. PARAMEDICS CHECKED BLOOD GLUCOSE AND IT WAS ABOVE 40 MG/DL. CUSTOMER'S MOTHER STATED HER BLOOD GLUCOSE PRIOR TO THE SEIZURE WAS 105 MG/DL. CUSTOMER'S MOTHER WANTED TO TROUBLESHOOT THE METER AND DECLINED TO TROUBLESHOOT THE INSULIN PUMP. CUSTOMER'S MOTHER STATED THE DEVICE HAS BEEN DOING FIND. MOST CURRENT BLOOD GLUCOSE WAS 205 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509454 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention