BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 1970177 · Received January 25, 2011

    Report

    Report Number
    1415939-2011-00019
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO RETURN MATERIAL WAS MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. THE EVALUATION BEGAN WITH A REVIEW OF THE MANUFACTURING, TESTING AND STABILITY DATA FOR REAGENT LOT (B)(4). ALL RELEASE SPECIFICATIONS AND TEST RESULTS ARE ACCEPTABLE. THIS REAGENT IS ALSO USED AS A REFERENCE MATERIAL AND HAS CONSISTENTLY GENERATED VALID CALIBRATION CURVES AND CONTROL RESULTS. ACCURACY OF RECOVERY STUDIES WERE ALSO RECENTLY PERFORMED ON A SUBLOT OF LOT (B)(4) AND GENERATED ACCEPTABLE RESULTS. THIS ASSAY'S PERFORMANCE IS ALSO MONITORED THROUGH PROFICIENCY TESTING, WHICH HAS TO DATE PERFORMED WITHOUT ISSUE. THE ARCHITECT TOTAL B-HCG ASSAY PACKAGE INSERT ((B)(4)) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. A SPECIFIC REASON FOR THE CUSTOMER'S ISSUE COULD NOT BE DETERMINED. HOWEVER, FROM THE CURRENT INVESTIGATION, IT CAN BE CONCLUDED THAT THE ARCHITECT TOTAL B-HCG ASSAY, LOT (B)(4), IS PERFORMING ACCEPTABLY. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. CATALOG NUMBER CHANGED FROM 7K78-25 TO 7K78-30. METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE FEMALE PATIENT GENERATED A FALSE POSITIVE RESULT OF 55 MIU/ML WITH THE ARCHITECT TOTAL B-HCG ASSAY ON THE ARCHITECT I2000 ANALYZER. FOUR DIFFERENT SAMPLES FROM THIS SAME PATIENT GENERATED ARCHITECT TOTAL B-HCG ASSAY RESULTS OF 55 MIU/ML. SAMPLES FROM THIS PATIENT WERE ALSO TESTED BY TWO DIFFERENT METHODOLOGIES (NON-ABBOTT) AND GENERATED NEGATIVE RESULTS. AN ULTRA-SOUND WAS PERFORMED ON THIS PATIENT AND WAS NEGATIVE. THERE IS NO FURTHER IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL B-HCG FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT LABORATORIES 89907JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000 ANALYZER LN:8C89-01 SN: (B)(4)| ARCH I2000 ANALYZER LN:8C89-01 SN: (B)(4)