BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2213767 · Received August 17, 2011

    Report

    Report Number
    2122870-2011-02944
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. SAMPLE WAS ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. FURTHER ANALYSIS WAS PERFORMED BY CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR THIS EVENT. THE CPLS INVESTIGATION SHOWED A POSSIBILITY OF PACK CONTAMINATION THAT MAY CAUSE QC OUT OF RANGE. HIGH QC RESULTS WERE OBTAINED ON TWO REAGENT PACKS USED IN LOT 071024 (REAGENT LOT USED DURING THE TIME OF THE EVENT). THIS CONTAMINATION IS LIMITED TO AND DO NOT EXPLAIN THE ERRATIC RESULTS DESCRIBED IN THIS COMPLAINT. BEC WOULD RECOMMEND TO THE CUSTOMER, IN CASE OF SIMILAR ISSUE, TO TRANSFER THE SAMPLE FROM THE ORIGINAL TUBE AND RE-CENTRIFUGED PRIOR TO RE-TEST. AFTER CENTRIFUGATION SAMPLE SHOULD BE HANDLED CAREFULLY TO AVOID CELLULAR DEBRIS RE-SUSPENSION THAT MAY INTERFERE WITH THE ASSAY. NO CLEAR ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING FALSE POSITIVE BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) RESULTS ON ONE (1) PATIENT'S SAMPLE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT'S RESULTS HAD YIELDED NEGATIVE ON A PREVIOUS SAMPLE AND WAS DISCORDANT TO AN ALTERNATE METHOD. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTE OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1