BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TOXO IGG REAGENT

    MDR report key: 1911409 · Received December 1, 2010

    Report

    Report Number
    1415939-2010-00547
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LGD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 9K08-20 AXSYM TOXO IGG REAGENT THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 3B22-22 AXSYM TOXO IGG REAGENT. AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). A RETAINED KIT OF AXSYM TOXO IGG REAGENT PACK, LIST NUMBER 9K08-20, LOT NUMBER 88603HN00 AND LOT NUMBER 90093HN00 WERE CALIBRATED. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. TO EVALUATE REAGENT SPECIFICITY, A SPECIFICITY PANEL WAS TESTED IN REPLICATES OF FIVE. SPECIFICITY PANEL VALUES MET SPECIFICATIONS AND THE RESULTS WERE IN THE TYPICAL RANGE BETWEEN 1.2 IU/ML AND 1.6 IU/ML FOR REAGENT LOT 88603HN00 AND 1.3 IU/ML TO 1.6 IU/ML FOR REAGENT LOT 90093HN00 AND NO FALSE REACTIVE RESULTS WERE OBTAINED. ADDITIONALLY, RETAINED SAMPLES OF BOTH REAGENT LOTS IDENTIFIED IN THE COMPLAINT WERE TESTED WITH AXSYM TOXO IGG CALIBRATORS AND CONTROLS ON TWO INSTRUMENTS WITH 1 REPLICATE OF NEGATIVE CONTROL AND POSITIVE CONTROL AND AN ADDITIONAL 30 REPLICATES OF EACH NEGATIVE TO EVALUATE THE REPRODUCIBILITY OF NON-REACTIVE SAMPLES. ALL CALIBRATIONS WERE VALID AND ALL CONTROL VALUES WERE WITHIN THE AXSYM TOXO IGG PACKAGE INSERT SPECIFICATIONS. THE MEAN RESULTS OF THE NEGATIVE CONTROL RESULTS OBTAINED WITH REAGENT LOT NUMBER 88603HN00 AND 90093HN00 WERE STATISTICALLY EQUIVALENT. THERE IS NO INDICATION THAT BOTH LOT NUMBERS DISPLAY AN UNUSUAL PERFORMANCE. AS PART OF THE EVALUATION THE COMPLAINT RECORDS OF LOT NUMBER 88603HN00 AND LOT NUMBER 90093HN00 WERE REVIEWED. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER OBSERVATION. BASED ON OUR EVALUATION, WE HAVE DETERMINED THAT AXSYM TOXO IGG REAGENT PACK, LIST NUMBER 9K08-20, LOT NUMBER 88603HN00 AND LOT NUMBER 90093HN00 ARE PERFORMING ACCEPTABLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SAMPLE PROCESSED USING THE AXSYM TOXO-IGG ASSAY GENERATED FALSELY POSITIVE RESULT OF 35 IU/ML. A REPEAT OF THIS SAMPLE YIELDED A NEGATIVE RESULT OF 0.1 AND 0.0 IU/ML. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOXO IGG REAGENT FOR THE MEASUREMENT OF IGG ANTIBODIES TO TOXOPLASMA GONDII LGD ABBOTT LABORATORIES 88603HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER LN 7A83-85 SN (B)(4)| AXSYM ANALYZER LN 7A83-85 SN (B)(4)