BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3222966 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02873
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 3, 2013
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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'S INSULIN PUMP SHOWS A BOLUS OF 11.2 UNITS BEING DELIVERED AT 3:00 AM. IT WAS STATED THAT THE CUSTOMER DID NOT PROGRAM THAT BOLUS AS SHE WAS ASLEEP AT THAT TIME. IT WAS THEN DETERMINED, AFTER LISTENING TO THE PHONE CALL, THAT THE CUSTOMER HAD BEEN HOSPITALIZED FOR DIABETIC KETOACIDOSIS, BUT NO OTHER INFORMATION WAS OBTAINED REGARDING THE EVENT. MADE SEVERAL PHONE CALLS TO THE INITIAL CALLER, WHICH WAS A DIABETES EDUCATOR. HOWEVER, WAS UNABLE TO REACH HER. LEFT HER SEVERAL VOICE MESSAGES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324072 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization