BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 1953015 · Received January 7, 2011

    Report

    Report Number
    1415939-2011-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 5, 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). THE EVALUATION BEGAN WITH A REVIEW OF THE MANUFACTURING, TESTING AND STABILITY DATA OF THE AFFECTED LOT. ALL RESULTS MET SPECIFICATIONS. REAGENT LOT 89909JN00 IS ALSO USED AS A REFERENCE LOT AND CONSISTENTLY MEETS ALL REQUIREMENTS FOR EACH TIME POINT TESTED. TESTING WAS ALSO PERFORMED TO ASSESS THE ACCURACY OF RECOVERY OF THIS LOT OF ARCHITECT TOTAL B-HCG REAGENT AND ALL SPECIFICATIONS WERE MET. AS NEGATIVE RESULTS WERE OBTAINED FOR THE PATIENT'S SAMPLE ON AN ALTERNATE METHOD AND USING THE ARCHITECT TOTAL B-HCG ASSAY FOLLOWING PRE-TREATMENT USING HETEROPHILIC BLOCKING TUBES, IT IS LIKELY THAT THE ELEVATED RESULTS MAYBE DUE TO INTERFERING SUBSTANCES. THE ARCHITECT TOTAL B-HCG 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. THE CURRENT EVALUATION IDENTIFIED NO PRODUCT MALFUNCTION AND THAT THE ASSAY IS MEETING ITS SAFETY AND EFFECTIVENESS CLAIMS. REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FEMALE PATIENT UNDERGOING IN-VITRO FERTILIZATION GENERATED THE FOLLOWING RESULTS WITH THE ARCHITECT TOTAL B-HCG ASSAY (EACH DATE REPRESENTS A DIFFERENT SAMPLE): DATE: (B)(6) 2010, RESULT: 19 MIU/ML REAGENT LOT 87919JN00; (B)(6) 2010, 20 MIU/ML; (B)(6) 2010, 18 MIU/ML; (B)(6) 2010, 29 MIU/ML REAGENT LOT 89908JN00; (B)(6) 2010, 30 MIU/ML; (B)(6) 2010, 36 MIU/ML; (B)(6) 2010, 30 MIU/ML; (B)(6) 2011, 25 MIU/ML. THE POSITIVE CUT-OFF FOR THE ASSAY IS 25 MIU/ML. THE PATIENT HAS TESTED NEGATIVE WITH A NON-ABBOTT ASSAY. THE SAMPLE FROM (B)(6) 2011 WAS TREATED WITH A HETEROPHILIC BLOCKING TUBE AND RETESTED ON THE ARCHITECT PLATFORM WITH A NEGATIVE RESULT (LESS THAN 1.2 MIU/ML). THERE IS NO IMPACT TO PATIENT MANAGEMENT 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 89908JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR ANALYZER LN: 3M74-02 SN: (B)(4)| ARCH I2000SR ANALYZER LN: 3M74-02 SN: (B)(4)