BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-G

    MDR report key: 7879560 · Received September 14, 2018

    Report

    Report Number
    3002809144-2018-00341
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Report Date
    November 16, 2018
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE IS ARCHITECT HAVAB IGG LIST NUMBER 06C29 LOT 87317LI00. THE EVENT DOCUMENTED HAS BEEN ASSOCIATED WITH A PRODUCT RECALL. THE EVENT ASSOCIATED WITH THE UPDATED SUSPECT MEDICAL DEVICE (ARCHITECT HAVAB IGG ASSAY) IS NOT REPORTABLE PER 21CFR PART 806, AS THE PRODUCT HAS NOT BEEN DISTRIBUTED IN THE US. NO ADDITIONAL INFORMATION WILL BE PROVIDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C29 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C27. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY REACTIVE RESULTS WHILE USING ARCHITECT HAVAB-IGG REAGENTS. THE CUSTOMER STATED 23 SPECIMENS WERE INITIALLY REACTIVE OF 499 SPECIMENS TESTED AND LATER AN ADDITIONAL 5 SPECIMENS WERE INITIALLY REACTIVE OF 77 TESTED. THE CUSTOMER REPEATS ALL SPECIMENS WITH RESULTS BETWEEN 0.9 AND 1.2 S/CO. NO SPECIFIC VALUES PER SPECIMEN WERE PROVIDED. PER THE PRODUCT PACKAGE INSERT SPECIMENS WITH SIGNAL TO CUTOFF (S/CO) VALUES GREATER THAN OR EQUAL TO 1.00 ARE CONSIDERED REACTIVE FOR IGG ANTI-HAV. SPECIMENS WITH S/CO VALUES LESS THAN 1.00 ARE CONSIDERED NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718425 ARCHITECT HAVAB-G IGG ANTI-HAV LOL ABBOTT GERMANY 87317LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER| ARCHITECT I1000SR ANALYZER| LN 01L86-01 SN I1SR55226| LN 01L86-01 SN I1SR55226