BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON

    MDR report key: 52952 · Received November 20, 1996

    Report

    Report Number
    2050012-1996-00009
    Event Type
    Malfunction
    Date Received
    November 20, 1996
    Date of Event
    October 28, 1996
    Report Date
    November 7, 1996
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN RUNNING A GLUCOSE ON A PT SAMPLE, USING THE CX7, A RESULT OF 62 MG/DL WAS OBTAINED. THIS RESULT WAS QUESTIONED BY HOSP PERSONNEL. PT SAMPLE WAS RE-RUN WITH A RESULT OF 540 MG/DL. NO INJURY OR TREATMENT WAS ATTRIBUTED TO THE LOW GLUCOSE RESULT, HOWEVER A PHYSICIAN COULD HAVE ACTED UPON THE INCORRECT RESULT BY WITHHOLDING TREATMENT THAT OTHERWISE MIGHT HAVE BEEN INITIATED FOR A PT WITH A 540 GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CLINICAL CHEMISTRY ANALYZER S/W VER 4.0 + JJC BECKMAN INSTRUMENTS, INC. CX7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other