BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 925234 · Received October 9, 2007

    Report

    Report Number
    2122870-2007-00232
    Event Type
    Other
    Date Received
    October 9, 2007
    Report Date
    October 9, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMEN COLLECTION OR PROCESSING DATA WAS NOT PROVIDED. PER CUSTOMER, QC HAS BEEN IN RANGE. (A) REVIEW OF THE ARCHIVE FILES INDICATED NUMEROUS INSTANCES OF QC RESULTS WITH IND (RESULT BELOW ANALYTICAL RANGE OF THE ASSAY) OR OVR (RESULT ABOVE ANALYTICAL RANGE OF ASSAY) FLAGS. DURING A COMPARISON OF ARCHIVE FILES, PACK SHARING BETWEEN INSTRUMENTS WAS IDENTIFIED. SYSTEM CHECK DATA WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER LAB ON 9/17/2007 AND 9/19/2007: (A) THE FSE NOTED THAT CARRYOVER TESTING FAILED. SAMPLE PROBE WAS REPLACED BECAUSE THE FSE NOTED A DEFECTIVE RECESSED TEFLON TIP. (B) THE FSE REPLACED THE TRANSDUCER AFTER DISCOVERING THAT THE TRANSDUCER VOLTAGE WAS VARIABLE AND ULTRASONICS COULD NOT BE ADJUSTED. (C) THE FSE REALIGNED PIPETTORS AND REPLACED A DISPENSE PROBE. (D) THE FSE PERFORMED ALL TYPE 1 VERIFICATION PROTOCOL AND VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WHICH WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY INSTRUMENT FOR FOUR (4) PATIENTS. FOUR PATIENT SAMPLES WERE TESTED FOR ACCUTNI AND RESULTS OBTAINED WERE OVER 100NG/ML. (SEE B6). OVR (RESULT ABOVE ANALYTICAL RANGE OF ASSAY) FLAGS WERE GENERATED ALONG WITH THESE RESULTS. REPEAT ACCUTNI TESTING GAVE "NORMAL" RESULTS. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA