BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 813745 · Received January 16, 2007

    Report

    Report Number
    2122870-2007-00007
    Event Type
    Other
    Date Received
    January 16, 2007
    Date of Event
    December 22, 2006
    Report Date
    January 16, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS IN THE CUSTOMER'S LAB ON 12/22/06. A) THE FSE CONDUCTED A PARTIAL SYSTEM CHECK WHICH PASSED. THE CUSTOMER CALLED BECKMAN COULTER INC. (BC) AND STATED THAT QC WAS OUT ON MULTIPLE ASSAYS ON 12/23/06. CUSTOMER TECHNICAL SERVICE (CTS) HAD CUSTOMER RUN SYSTEM CHECK WHICH FAILED ALL SPECIFICATIONS. CTS HAD CUSTOMER CHECK ASPIRATE PROBES AND THEY FOUND OUT THAT ASPIRATE PROBE #2 WAS MISSING ALONG WITH PERI-PUMP TUBING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB ON 12/23/07 TO ADDRESS THE HARDWARE ISSUES. IN A FOLLOW UP WITH THE CUSTOMER ON 01/03/07, THEY STATED THAT THE INSTRUMENT HAS BEEN WORKING WELL SINCE ITS REPAIR. HARDWARE ISSUES ADDRESSED BY THE FSE HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY HIGH TROPONIN (ACCU TNL) RESULTS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. A SERIAL DRAWING WAS PERFORMED ON A PT AND ACCU TNL RESULTS WERE OBTAINED AS FOLLOWS: SAMPLE 1: 0.04NG/ML. SAMPLE 2: 0.54NG/ML. SAMPLE 3: "<0.04NG/ML." FOLLOWING THE EVENT, THE CUSTOMER PERFORMED SYSTEM CHECK WHICH FAILED AND NOTED HARDWARE PROBLEMS. THE CUSTOMER THEN SENT ALL SAMPLES OUT OF ANOTHER LAB FOR TESTING. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH 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