BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2021244 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00550
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT INTO DIABETIC KETOACIDOSIS, AND REQUIRED ASSISTANCE BY A HEALTH PROFESSIONAL. THE CUSTOMER WAS ALSO GETTING MULTIPLE NO DELIVERY ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization