BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS® TOXO IGG

    MDR report key: 2461255 · Received February 17, 2012

    Report

    Report Number
    2122870-2012-00355
    Date Received
    February 17, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LGD
    PMA / PMN Number
    K080869
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR PREPARATION INFORMATION WAS SUPPLIED. QC RESULTS BEFORE AND AFTER THE EVENT WERE WITHIN THE ESTABLISHED RANGES. THE CUSTOMER SENT TWO SAMPLES FROM THE PATIENT TO BECKMAN COULTER FOR TESTING. THE TESTING ON THE CENTRIFUGED SAMPLES AT BECKMAN COULTER ON (B)(6) 2012 PRODUCED NON-REACTIVE RESULTS AND DID NOT REPRODUCE THE CUSTOMER'S RESULTS. INVESTIGATION DID NOT DEMONSTRATE A REAGENT ISSUE. ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED, BUT A PRE-ANALYTICAL STEP ISSUE MAY BE THE ROOT CAUSE OF THIS PHENOMENON. BECKMAN COULTER RECOMMENDS THEREFORE TO FOLLOW TUBE MANUFACTURER INSTRUCTIONS IN TERM OF CLOTTING TIME, TUBE MIXING (NUMBER OF INVERSIONS WHEN MIXING BLOOD), SPEED AND G FORCE WHEN SPINNING. WE WOULD RECOMMEND TO CUSTOMER IN CASE OF SIMILAR ISSUE, TO TRANSFER THE SAMPLE FROM THE ORIGINAL TUBE AND RE-CENTRIFUGED PRIOR TO RE-TEST. IF RESULT REMAINS THE SAME, CUSTOMERS SHOULD SEND THE SAMPLES AS WELL AS ARCHIVE DATA FILE TO BECKMAN COULTER FOR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO ERRONEOUS REACTIVE TOXOPLASMA IGG RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PREGNANT INPATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY THE PHYSICIAN. REPEAT TESTING ALSO PRODUCED REACTIVE RESULTS, BUT SUBSEQUENT TESTING BY AN ALTERNATE METHODOLOGY PRODUCED NON-REACTIVE RESULTS. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. INFORMATION REGARDING THE ACCESS 2 IMMUNOASSAY ANALYZER IS LISTED BELOW: CATALOGUE NUMBER: 81600N, SERIAL NUMBER: (B)(4), DATE OF MANUFACTURE: 10/23/2002, PRODUCT CODE: JJE, DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE, 510(K) NUMBER: K922823/A007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® TOXO IGG TOXOPLASMA GONDII SEROLOGICAL REAGENTS LGD BECKMAN COULTER, INC. ACCESS TOXO IGG 192839

    Patients

    Seq Age Sex Outcome Treatment
    1