BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2060331 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01003
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 18, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE STORED FROZEN OVER THE WEEKEND, THAWED AND THEN BATCHED FOR THE MONDAY MORNING RUN. QC HAD BEEN WITHIN THE ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. ADDITIONAL SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE TRANSDUCER AS A PREVENTATIVE MEASURE. THE FSE PERFORMED A 30 REPLICATE PRECISION TEST USING THE LOW LEVEL HYB-PSA QC MATERIAL. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. THE FSE ALSO VERIFIED PIPETTOR ALIGNMENTS. NO ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE WITH THE DATA SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOWER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB PSA) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, GENERATED BY ACCESS 2 IMMUNOASSAY CLINICAL SYSTEM FOR TWENTY SIX (26) PATIENTS' SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS OUTSIDE OF ASSAY PRECISION CLAIMS, AND THE REPORTS WERE CORRECTED. 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