BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® TOXO IGG

    MDR report key: 3203152 · Received July 2, 2013

    Report

    Report Number
    2122870-2013-00591
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 6, 2013
    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 THE ACCESS TOXO IGG DEVICE WAS RETURNED FOR EVALUATION. BETWEEN (B)(4) 2013, QUALITY CONTROL (QC) LEVELS RECOVERY INDICATED GOOD PRECISION. SYSTEM CHECKS, PERFORMED ON (B)(4) 2013, PASSED FOR ALL MEASURED PARAMETERS. CALIBRATION, DATED ON (B)(4) 2013, WAS WITHIN SPECIFICATIONS. IN CONCLUSION, THE CUSTOMER'S ARCHIVE DATA ANALYSIS DOES NOT INDICATE AN INSTRUMENT ISSUE. FURTHERMORE, THE TOXO IGG (TOXOPLASMA GONDII ANTIBODY) ASSAY WAS PERFORMING WITHIN PERFORMANCE SPECIFICATIONS. PATIENT SAMPLE WAS NOT SUPPLIED FOR FURTHER ANALYSIS. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED DISCORDANT TOXO IGG (TOXOPLASMA GONDII ANTIBODY) RESULTS FOR ONE PATIENT INVOLVING THE ACCESS TOXO IGG ASSAY UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT ANALYSIS OF THE FIRST PATIENT SAMPLE, ON THE SAME INSTRUMENT, PRODUCED TWO REACTIVE RESULTS AND ONE NON-REACTIVE RESULT AND A REACTIVE RESULT ON A SECOND SAMPLE. THE SECOND SAMPLE WAS ALSO ANALYZED BY A REFERENCE LABORATORY AND OBTAINED A NON-REACTIVE RESULT. THE CUSTOMER STATED THE DISCORDANT RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. FOR EACH TOXO IGG RESULT, THE TOXO IGM ASSAY WAS ALSO ANALYZED AND PRODUCED A NON-REACTIVE RESULT. ALL SYSTEM PARAMETERS, INCLUDING QUALITY CONTROL (QC), CALIBRATIONS AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302864 ACCESS® TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD BECKMAN COULTER NA 392846

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR