BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 2548594 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00021
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    January 2, 2012
    Report Date
    April 16, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METER REQUESTED FROM CUSTOMER. REPORT WILL BE UPDATED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PRESTO METER GAVE GLUCOSE VALUE OF 400 MG/DL. WENT TO HOSPITAL, HOSPITAL METER (BRAND UNK) GAVE 256 MG/DL. PT TREATED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTO BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOLSE METER NBW AGAMATRIX, INC. HY14WW38E

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other