BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4123351 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29550
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THEY HAD A NO DELIVERY ALARM, BUT THE INSULIN DID EXIT. THE BLOOD GLUCOSE READING IS 140 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602626 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A HG05YJ0

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR