BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2071235 · Received April 27, 2011

    Report

    Report Number
    2122870-2011-01173
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC SAMPLE INFORMATION INCLUDING CENTRIFUGATION HAVE NOT BEEN SUPPLIED TO DATE. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE MORNING OF THE EVENT. AT THE TIME OF THE EVENT, QC WAS NOT PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR ACCUTNI. A SYSTEM CHECK PERFORMED BY THE CUSTOMER FAILED TO MEET INSTRUMENT SPECIFICATIONS WITH VERY HIGH %CV VALUES. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE NOTED "CLOT" STUCK ON PROBE #1 TIP. FSE REPLACED THE OBSTRUCTED PROBE AND INCUBATOR BELT. FSE VERIFIED HARDWARE BY PERFORMING A SYSTEM CHECK, WHICH WAS WITHIN INSTRUMENT SPECIFICATIONS AND QC WAS WITHIN CUSTOMER'S ESTABLISHED LIMITS. THE ROOT CAUSE IS ASSOCIATED WITH THE OBSTRUCTED ASPIRATE PROBE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS IMMUNOASSAY ANALYZER FOR FIVE (5) PATIENTS' SAMPLES. RESULTS WERE REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN AS THEY DID NOT MEET THE CLINICAL PICTURE OF THE PATIENTS. REPEAT ANALYSIS OF THE SAMPLES ON AN ALTERNATE INSTRUMENT GAVE LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. RESULTS ARE SHOWN. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1