BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2052239 · Received April 12, 2011

    Report

    Report Number
    1415939-2011-00099
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 4, 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). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C21. AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. TO ADDRESS THE CUSTOMER'S ISSUE, A REVIEW OF RECENT MANUFACTURING AND TESTING DATA FOR THE AFFECTED LOT (ARCHITECT TOTAL B-HCG, LIST NUMBER 7K78-25, LOT NUMBER 96932JN00) WAS PERFORMED. THIS REVIEW INDICATED THAT THE REAGENTS WERE RELEASED WITHIN SPECIFICATION AND THAT NO ISSUES WERE IDENTIFIED THAT COULD AFFECT THE PERFORMANCE OF THE ASSAY. A REVIEW OF THE ARCHITECT I2000SR ANALYZER'S INSTRUMENT RESULT LOG DID NOT IDENTIFY ANY ANOMALIES OR INTERFERENCES IN THE DARK READ OR SIGNAL READ FOR THE SAMPLE IN QUESTION. IN ADDITION, THE REAGENT LOT IN QUESTION WAS USED IN A CARRYOVER STUDY. RESULTS OBTAINED DID NOT DEMONSTRATE CARRYOVER UNDER THE EXPERIMENTAL CONDITIONS. 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 ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT TOTAL B-HCG ASSAY PACKAGE INSERT BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S ISSUE. IN CONCLUSION, IT CAN BE CONCLUDED THAT NO PRODUCT DEFICIENCY HAS BEEN IDENTIFIED FOR THE ARCHITECT TOTAL B-HCG ASSAY. THE INVESTIGATION DEMONSTRATED THAT SAFETY EFFECTIVENESS AND LABEL CLAIMS WERE MET AND THAT THE ASSAY IS CURRENTLY PERFORMING ACCEPTABLY. CATALOG NUMBER, CHANGED TO 7K78-25. EVALUATION , METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A FALSE POSITIVE ARCHITECT TOTAL B-HCG ASSAY RESULT. ON (B)(6) 2011, A PATIENT SAMPLE GENERATED AN ARCHITECT TOTAL B-HCG ASSAY RESULT OF 1291 MIU/ML. ON (B)(6) 2011, A NEW SAMPLE WAS TAKEN FROM THE SAME PATIENT AND GENERATED AN ARCHITECT TOTAL B-HCG ASSAY RESULT OF NEGATIVE (SPECIFIC VALUE NOT PROVIDED). ON (B)(6) 2011, ANOTHER SAMPLE WAS TAKEN FROM THE SAME PATIENT AND GENERATED AN ARCHITECT TOTAL B-HCG ASSAY RESULT OF NEGATIVE (SPECIFIC VALUE NOT PROVIDED). THE SAMPLE FROM (B)(6) 2011 WAS THEN RECENTRIFUGED AND RETESTED AND GENERATED AN ARCHITECT TOTAL B-HCG ASSAY RESULT OF NEGATIVE (SPECIFIC VALUE NOT PROVIDED). CONTROLS HAVE BEEN WITHIN SPECIFICATIONS ON ALL DAYS OF TESTING. 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 96932JN00

    Patients

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