BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX7, DELTA

    MDR report key: 154842 · Received March 2, 1998

    Report

    Report Number
    MW4002063
    Event Type
    Malfunction
    Date Received
    March 2, 1998
    Date of Event
    January 2, 1998
    Report Date
    January 15, 1998
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE CLINICAL LAB, INCORRECT RESULTS FROM THE CX7-DELTA INSTRUMENT WERE REPORTED FOR APPROX 12 HOURS WITH NO WARNING TO OPERATOR. SODIUM AND CHLORIDE RESULTS WERE INCORRECT BECAUSE OF A SERUM CLOT IN THE ANALYTICAL PATHWAY (DISCOVERED BY MFR'S SERVICE REP). MAGNESIUM AND PHOSPHORUS RESULTS, AS WELL AS OTHER CHEMISTRY VALUES, WERE ALSO INCORRECTLY REPORTED. THE MFR'S VERBAL REPORT ATTRIBUTED THOSE FALSE VALUES TO A LOOSER MIXER PADDLE. 160 SPECIMENS HAD TO BE RE-ANALYZED, PTS RECORDS EDITED, AND CLINICIANS NOTIFIED. PT TREATMENT DECISIONS HAD BEEN MADE ON FALSE VALUES. ALTHOUGH ONE PT WAS CRITICALLY ILL AND HIS CARE WAS COMPLICATED BY THE TREATMENT PLAN BASED ON THE FALSE VALUES, IT CANNOT BE DETERMINED IF HIS CONDITION WORSENED AS A RESULT OF THAT INITIAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX7, DELTA AUTOMATED CHEMISTRY ANALYZER JJC BECKMAN INSTRUMENTS, INC. CX4, CX7, DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other