BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3182805 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02557
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS GREATER THAN 400 MG/DL. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER WAS TREATED WITH JUICE AND SUGAR FOR A LOW BLOOD GLUCOSE OF 55 MG/DL. UNABLE TO TROUBLESHOOT WITH THE CALLER AS SHE HAD NO (B)(6) CONSENT. MADE SEVERAL ATTEMPTS TO REACH THE CUSTOMER DAYS LATER, BUT THERE WAS NO ANSWER. LEFT MESSAGES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283268 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization