BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2001249 · Received February 24, 2011

    Report

    Report Number
    2122870-2011-00496
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM CHECK RESULTS FROM (B)(6) 2011, (B)(6) 2011, AND (B)(6) 2011 SHOWED SOME ERRATIC RECOVERIES OF THE WASHED %CV BUT STILL WITHIN THE PUBLISHED SPECIFICATIONS. ALL OTHER PORTIONS WERE WITHIN THE SPECIFICATIONS. QC HAD BEEN WITHIN THE ESTABLISHED RANGES FOR THE LAST 30 DAYS. QC HAD BEEN SHIFTING HIGH AND LOW, THOUGH WITHIN THE ESTABLISHED RANGES, SINCE REAGENT LOT 014441 WAS CALIBRATED WITH CALIBRATOR LOT 009726 ON (B)(6) 2011. THE CUSTOMER BEGAN GETTING IND/NO VALUE RESULTS ON QC. THE CUSTOMER CALIBRATED USING A NEW CALIBRATOR KIT AT THE ADVICE OF BCI HOTLINE. QC AND PREVIOUS PATIENTS' RESULTS RECOVERED AS EXPECTED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO DEFINITIVE ROOT CAUSE HAS BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO HIGHER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB PSA) RESULTS WITHIN NORMAL REFERENCE RANGE GENERATED BY ACCESS 2 IMMUNOASSAY CLINICAL SYSTEM FOR 10 PATIENTS' SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORTS 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® 2 IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LTJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1