BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3900927 · Received June 27, 2014

    Report

    Report Number
    2032227-2014-03407
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2014-03408.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SHE HAD LOW AND HIGH BLOOD GLUCOSE AND KETOACIDOSIS. CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED AND SHE WAS TAKEN TO THE HOSPITAL. CUSTOMER STATED THAT SHE WAS IN DKA, BUT THE BLOOD GLUCOSE READING WAS LOW WHEN THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT SHE IS A BRITTLE DIABETIC AND DUE TO STRESS, HER BLOOD GLUCOSE WAS HIGH TO LOW. CUSTOMER STATED THAT SHE NEEDS A NOW SERTER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376741 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization