BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 CLINICAL SYSTEM

    MDR report key: 2079506 · Received May 5, 2011

    Report

    Report Number
    2050012-2011-01315
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS URINE. CALIBRATION AND QC PRIOR TO THIS EVENT SHOWED NO PROBLEMS. CUSTOMER DID NOT REPORT OTHER PROBLEMS WITH OTHER DRUGS OF ABUSE OR OTHER ANALYTES ON THIS SYSTEM. CUSTOMER REPORTS ALL POSITIVE RESULTS WITHOUT CONFIRMATORY TESTING AND THEN WAITS FOR THE PHYSICIAN TO REQUEST FURTHER CONFIRMATORY TESTING. CUSTOMER IS AWARE OF BCI LABELING INDICATING ALL POSITIVE SCREENING RESULTS MUST BE CONFIRMED PRIOR TO REPORTING TO THE PHYSICIAN. SERVICE WAS NOT REQUESTED OR INITIATED FOR THIS EVENT. IT IS SAMPLE SPECIFIC EVENT. THE CLAIMED LIST OF DRUGS BY THE PATIENT WAS GIVEN TO BCI FOR INVESTIGATION WITH THE REAGENT VENDOR. ROOT CAUSE IS UNKNOWN AT THIS TIME FOR THE FALSE POSITIVE RESULT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND REPORTED THAT ONE AMPHETAMINE (AMPH) PATIENT RESULT OF POSITIVE WAS REPORTED OUT OF THE LAB PRIOR TO PERFORMING THE BCI RECOMMENDED CONFIRMATORY TESTING. BASED ON GC/MS METHOD TESTING, RESULT WAS NEGATIVE FOR BOTH AMPHETAMINES AND METHAMPHETAMINES. THE RESULT WAS NOT AMENDED. THE LABORATORY WILL ADD THE GC/MS (CONFIRMATORY METHOD) RESULT TO THE PATIENT RECORD, BUT WILL NOT REMOVE THE AMPH (SCREENING METHOD) RESULT FROM THE PATIENT RECORD. CUSTOMER WAS UNABLE TO DETERMINE WHETHER PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20, WO CAP PIERCER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1