BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYVA 30R (WITH BAR CODE READER)

    MDR report key: 124009 · Received September 29, 1997

    Report

    Report Number
    2917681-1997-00001
    Event Type
    Malfunction
    Date Received
    September 29, 1997
    Date of Event
    September 16, 1997
    Report Date
    September 29, 1997
    Manufacturer
    TOSHIBA CORP
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A ZERO RESULT WAS OBTAINED WITH CREATININE REGENTS (MFG BY ANOTHER CO) WHEN RUNNING THOSE REGENTS ON THE BEHRING DIAGNOSTICS SYVA 30R (FORMERLY THE WAKO 30R). THE 30R IS A GENERAL PURPOSE BIOCHEMICAL ANALYZER WHICH HAS A BAR CODE READER FOR READING SAMPLE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYVA 30R (WITH BAR CODE READER) GENERAL PURPOSE BIOCHEMICAL ANALYZER JJE TOSHIBA CORP 30R *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other