BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® TOXO IGG

    MDR report key: 3809231 · Received May 13, 2014

    Report

    Report Number
    2122870-2014-00367
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    November 21, 2013
    Report Date
    April 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    LGD
    PMA / PMN Number
    K080869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS® TOXO IGG DEVICE WAS RETURNED FOR EVALUATION. THE CUSTOMER-SUPPLIED PATIENT SAMPLES WERE FIRST TESTED NEAT AFTER CENTRIFUGATION AND CONFIRMED THE CUSTOMERS RESULTS. AN INTERFERENCE TESTING FOLLOWED, UTILIZING A MIX OF DIFFERENT BLOCKERS. HOWEVER, THE TESTING DID NOT DETECT ANY INTERFERENCE SINCE NONE OF THE BLOCKERS USED WERE ABLE TO MODIFY THE SIGNAL. THE SAMPLES WERE THEN ANALYZED BY GEL FILTRATION CHROMATOGRAPHY (GFC). THE CHROMATOGRAPHIC ANALYSIS REVEALED THAT THE ELUTION FRACTIONS, CORRESPONDING TO THE MOLECULAR WEIGHT OF IGG (150 KDA), WERE HIGHLY REACTIVE WITH THE ACCESS® TOXO IGG ASSAY. THE SPECIFICITY OF IGG COULD NOT BE INVESTIGATED DUE TO THE LOW VOLUME OF SAMPLE PROVIDED. IN CONCLUSION, THE CAUSE OF THE EVENT IS LIKELY DUE TO THE PRESENCE OF IGG REACTIVE DUE TO THE PRESENCE OF IGG REACTIVE WITH THE ACCESS® TOXO IGG ASSAY. HOWEVER, A DEFINITIVE CAUSE OF THE DISCORDANT RESULTS, WITH THE ALTERNATE METHODOLOGIES, COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. NOTE: CONCERNING THE DISCREPANCY BETWEEN THE ACCESS® RESULTS AND VALUES OBTAINED THROUGH ALTERNATE METHODOLOGIES, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE SPECIFICITY AND SENSITIVITY OF THE ACCESS® ASSAY ARE RESPECTIVELY 99.5% AND 98%. DESPITE THE FACT THAT SUCH FIGURES ARE THE PROOF A HIGH PERFORMANCE LEVEL, THE FIGURES ALSO INDICATE THAT A VERY LOW RATE OF DISCORDANT RESULTS IS TO BE EXPECTED. AS FOR ALL SEMI-QUANTITATIVE ASSAYS, THE ACCESS® RESULTS SHOULD BE, THEREFORE, INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00366; 2122870-2014-00367; 2122870-2014-00368; 2122870-2014-00369.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSE POSITIVE (REACTIVE) TOXO IGG RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS® TOXO IGG ASSAY USED IN CONJUNCTION WITH TWO UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEMS. THIS REPORT IS TWO OF FOUR REFERENCING THE EVENT DATE NOTED. THE CUSTOMER INDICATED THE RESULTS WERE DISCORDANT TO FIVE ALTERNATE METHODOLOGIES, WHICH GENERATED NEGATIVE TOXO IGG RESULTS. THE CUSTOMER INDICATED THE FALSE POSITIVE RESULTS WERE RELEASED OUT OF THE LABORATORY. HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT'S SAMPLES WERE COLLECTED IN 7 ML BECTON DICKINSON (BD) TUBE WITH GEL AND CENTRIFUGED AT 2,500 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES. NO INSTRUMENT ISSUES WERE REPORTED. THE CUSTOMER SUPPLIED BECKMAN COULTER WITH THE PATIENT'S SAMPLES FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287216 ACCESS® TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD BECKMAN COULTER NA 392849

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR