BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 746481 · Received July 25, 2006

    Report

    Report Number
    2050012-2006-00019
    Event Type
    Other
    Date Received
    July 25, 2006
    Date of Event
    July 4, 2006
    Report Date
    July 25, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PERFORMED IN THE MORNING OF 7/4/06 PASSED. THE PTS' SAMPLES WERE TESTED BETWEEN 13:10 IN 06 AND 6:17 ON THE FOLLOWING DAY. QC CONDUCTED ABOUT 6:30 WAS REPORTED WITH GREATER THAN 2SD LOW FOR MULTIPLE CARTRIDGE CHEMISTRIES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB ON THE SAME DAY. THE FSE IMMEDIATELY FOUND THAT A PLASTIC COVER ON THE SAMPLE CAROUSEL WAS REMOVED AND THEN PLACED NOT IN PROPER POSITION. AFTER THE SAMPLE COVER WAS SET IN PROPER POSITION, QC RECOVERED WITHIN SPECIFICATIONS. THE PLASTIC COVER ON THE SAMPLE CAROUSEL PLACED NOT IN PROPER POSITION CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING FALSELY LOW RESULTS FOR 10 CARTRIDGE CHEMISTRIES THAT WERE GENERATED BY THE SYNCHROM LX I 725 INSTRUMENT. THE CUSTOMER INDICATED THAT LOW RESULTS WERE REPORTED FOR 9 PTS. THE FOLLOWING CHEMISTRIES WERE AFFECTED: ALKALINE PHOSPHATASE (ALP), ALANINE AMINOTRANSFERASE (ALT), AMYLASE (AMY), ASPARTATE AMINOTRANSFERASE (AST), CREATINE KINASE (CK), ALCOHOL (ETOH), GENTAMICIN (GEN), LIPASE (LIP), PHENYTOIN (PHY) AND TOTAL BILIRUBIN (TBIL). ALL SAMPLES WERE RE-TESTED AND CORRECT RESULTS WERE OBTAINED: (SEE B6 FOR INITIAL AND REPEATED RESULTS). UNKNOWN IF PT TREATMENT WAS AFFECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA