BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3852318 · Received June 5, 2014

    Report

    Report Number
    2032227-2014-02911
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 MEDWATCH REPORT # 2032227-2014-02914.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT IN (B)(6) 2014, SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING AT THE TIME WAS 33 MG/DL. SHE ALSO REPORTED HIGH BLOOD GLUCOSE LEVELS OVERNIGHT ON ANOTHER OCCASION. THE BLOOD GLUCOSE READING WAS 600 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328743 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX A2751NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization