BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2992656 · Received March 7, 2013

    Report

    Report Number
    2032227-2013-00909
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 A HIGH BLOOD GLUCOSE OF 700 MG/DL. IT WAS STATED THAT THE CUSTOMER RECEIVED SEVERAL MOTOR ERROR ALARMS, BUT HE HAD NOT NOTICED UNTIL IT WAS TOO LATE. IT WAS STATED THAT THE CUSTOMER SLIPPED INTO A COMATOSE STATE FOR APPROXIMATELY FIVE HOURS. IT WAS STATED THAT THE CUSTOMER WAS USING A LOANER INSULIN PUMP WHILE HE UPGRADED. IT WAS STATED THAT HE HAS RECEIVED HIS UPGRADED INSULIN PUMP, AND HAS NOT HAD ANY ISSUES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97039 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization