BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3884491 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03113
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 1, 2004
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    THE PATIENT'S MOTHER STATED THAT THE PATIENT HAD BEEN HOSPITALIZED TWICE IN THE PAST 20 YEARS. THE MOTHER DID NOT REMEMBER MUCH AS IT WAS SO LONG AGO. THE FIRST EVENT WAS IN (B)(6) 2004, AND THE PATIENT'S BG WAS 30 MG/DL. THE PATIENT WAS NOT FEELING WELL, AND SHE WAS NOT HOME TO ASSIST HIM SO, HE CALLED 911. THE SECOND EVENT WAS IN (B)(6) 2011, AND THE PATIENTS BGS WERE BETWEEN 20 AND 30 MG/DL. THE MOTHER STATED THAT THE PATIENT SEEMED CONFUSED WHEN HE WOKE UP SO, SHE GAVE HIM EGG NOG. SHE MUST HAVE GIVEN HIM TOO MUCH BECAUSE, HIS BGS WENT UP TO 400 MG/DL. SHE STATED THAT SHE GAVE HIM A BOLUS AND HE WAS FINE BY MORNING. THESE EVENTS WERE WITH DIFFERENT PUMPS, AND THE MOTHER DID NOT KNOW THE SERIAL NUMBERS OR MODEL NUMBERS AS THIS WAS YEARS AGO. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361208 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization