BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRON

    MDR report key: 81254 · Received March 31, 1997

    Report

    Report Number
    2050012-1997-00004
    Event Type
    Death
    Date Received
    March 31, 1997
    Date of Event
    March 2, 1997
    Report Date
    March 24, 1997
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A PT WAS ADMITTED TO THE HOSP WITH A KNOWN DIAGNOSIS OF "THEOPHYLLINE OVERDOSE-ATTEMPTED SUICIDE". THE FACILITY STATED THAT THE PT ALSO HAD AN EXTREMELY HIGH ALCOHOL LEVEL (0.24 GM%). WHILE PERFORMING THE THEOPHYLLINE ASSAY FOR THIS PT, THE OPERATOR MISINTERPRETED A "RESULT SUPPRESSED-OIR" (OUT OF INSTRUMENT RANGE) AND PROCEEDED WITH ADD'L ANALYSIS WITHOUT CONSULTING PRODUCT LABELING. THE OPERATOR DILUTED THE SPECIMEN WITH THEOPHYLLINE CALIBRATOR AND OBTAINED A SECOND "RESULT SUPPRESSED-OIR". THE OPERATOR DID NOT DILUTE THE SPECIMEN FURTHER BUT REPORTED THE RESULT AS LESS THAN THE LOWER LIMIT OF THE ANALYTICAL RANGE OF THE INSTRUMENT (<2.0 UG/ML). THE INSTRUMENT PERFORMED AS EXPECTED AND CORRECTLY FLAGGED THE INITIAL SPECIMEN AND SUBSEQUENT DILUTION AS BEING OUT OF THE MEASURING RANGE. NO QUANTITATIVE RESULT WAS OBTAINED. THE FACILITY HAS ACKNOWLEDGED THE OPERATOR'S FAILURE TO CONSULT PRODUCT LABELING OR TO PERFORM ADD'L DILUTIONS AND HAS IMPLEMENTED A NEW LABORATORY POLICY WITH REGARD TO OUT OF RANGE SPECIMENS. SUBSEQUENT ANALYSIS OF A PROPERLY DILUTED SPECIMEN PRODUCED A THEOPHYLLINE RESULT OF >120 UG/ML. THE PT EXPIRED APPROX 4 HRS AFTER THE INITIAL RESULT WAS REPORTED. THIS IS BEING REPORTED BASED UPON THE FACILITY'S INDICATION THAT THE OPERATOR'S ERROR AND MISINTERPRETED RESULT MAY HAVE CONTRIBUTED TO A DELAY IN AGGRESSIVE PT CARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death