BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3222978 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02888
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 700 MG/DL. IT WAS STATED THAT THE INSULIN PUMP GAVE A BATTERY OUT LIMIT ALARM, AND THE CUSTOMER THOUGHT THE INSULIN PUMP HAD BROKEN, SO SHE TOOK IT OFF. THE CUSTOMER TRIED SEVERAL BATTERIES, BUT COULDN'T GET ONE TO WORK. THE MOTHER STATED THAT THE INSULIN PUMP IS WORKING FINE NOW, AND TROUBLESHOOTING IS NOT NECESSARY. THE MOTHER WAS ABLE TO CLEAR THE ALARM AND PROGRAM THE TIME AND DATE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324145 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization