BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-G

    MDR report key: 7731541 · Received July 30, 2018

    Report

    Report Number
    3002809144-2018-00097
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    June 29, 2018
    Report Date
    December 6, 2018
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DOCUMENTED HAS BEEN ASSOCIATED WITH A PRODUCT RECALL. THE EVENT ASSOCIATED WITH THE SUSPECT MEDICAL DEVICE ARCHITECT HAVAB IGG REAGENTS IS NOT REPORTABLE PER 21CFR PART 806, AS THE PRODUCT HAS NOT BEEN DISTRIBUTED IN THE US. NO FURTHER FOLLOW UPS WILL BE PROVIDED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C29 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L27.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE REACTIVE HAVAB IGG RESULTS ONE PATIENT SAMPLE. THE RESULTS PROVIDED FOR SERIAL NUMBER (B)(4) WERE: SID (B)(6) ON (B)(6) 2018 = 0.36 S/CO (<1.00S/CO = NONREACTIVE) / 1.05 S/CO (>/=1.00S/CO = REACTIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574912 ARCHITECT HAVAB-G IGG ANTI-HAV LOL ABBOTT GERMANY 86040LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| SERIAL # (B)(4).| SERIAL # (B)(4).| ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| SERIAL # (B)(4).