BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2179387 · Received July 26, 2011

    Report

    Report Number
    2122870-2011-02394
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED IN A SERUM TUBE WITH A GEL SEPARATOR. THE CUSTOMER CENTRIFUGES SAMPLES FOR 20 MINUTES AT ROOM TEMPERATURE IN A FIXED ANGLE CENTRIFUGE. THE CUSTOMER THEN TRANSFERS AND ANALYZES THE SAMPLE FROM A SECONDARY TUBE. CENTRIFUGATION SPEED WAS NOT PROVIDED. PER THE CUSTOMER, BOTH LEVELS OF HYB-PSA QC HAVE BEEN WITHIN THE CUSTOMER ESTABLISHED RANGES. SPECIFIC QC DATA WAS NOT PROVIDED. THE CUSTOMER NOTED THAT THERE HAVE BEEN NO ISSUES TO REPORT REGARDING SYSTEM CHECKS, EVENT LOG ERROR MESSAGES OR OTHER ASSAYS TO DATE. ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. A ROUTINE SYSTEM CHECK, A 50 REPLICATE PRECISION TEST, AND A HIGH SENSITIVITY SYSTEM CHECK PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED MOD 10879 "ULTRASONICS - ADJUST TO FIXED 197 VOLTAGE". A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. ASSOCIATED MDRS FOR THIS EVENT: 2122870-2011-02366, 2122870-2011-02367.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A HIGHER THAN EXPECTED HYBRITECH PROSTATE-SPECIFIC ANTIGEN (HYB-PSA) FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS HYBRITECH PSA REAGENT (LOT 022757) AND ACCESS HYBRITECH PSA CALIBRATOR (LOT 022077). THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE PATIENT WAS DRAWN FOR ANOTHER SAMPLE WHICH WAS TESTED VIA AN ALTERNATE METHOD, GENERATED A RESULT THAT BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. 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® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1