BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 4132438 · Received October 1, 2014

    Report

    Report Number
    3002809144-2014-00180
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED (B)(6) PATIENT SAMPLES WHEREAS VIDAS WAS (B)(6) OR INDETERMINATE. A (B)(6), LOT NUMBER 40408LI00 WAS TESTED IN A CLINICAL (B)(6) SET UP, INCLUDING ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (BIOMEX SEROCONVERSION PANEL (B)(4)). RESULTS OF THIS SETUP DID NOT IMPLICATE THAT THE (B)(6) PERFORMANCE OF THE LOT IS (B)(6) IMPACTED. THE SEROCONVERSION PANEL WAS COMPARED WITH HISTORICAL DATA FROM (B)(6) LOT NUMBER 21153LI00. THE REAGENT DETECTED THE SAME BLEEDS AS (B)(6). ADDITIONALLY, A REVIEW OF NON-CONFORMANCES AND DEVIATIONS ASSOCIATED WITH THE AFFECTED (B)(6) LOT WAS PERFORMED. THIS REVIEW DID NOT REVEAL ANY EVENTS OR ISSUES THAT MAY HAVE IMPACTED THE PERFORMANCE OF THE LOT NUMBER IN RELATION TO THE COMPLAINT ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE (B)(6) PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT 3 SAMPLES GENERATED (B)(6) RESULTS WHEREAS VIDAS WAS (B)(6). ID (B)(4): (B)(6) RESULTS OF 0.90 AND 0.87 S/CO WERE GENERATED. VIDAS (B)(6). ID (B)(4): (B)(6) RESULTS OF 0.47 AND 0.48 S/CO WERE GENERATED. VIDAS (B)(6). ID (B)(4): (B)(6) RESULTS OF 0.86 AND 0.81 S/CO WERE GENERATED. VIDAS (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613072 ARCHITECT ANTI-HBC II ANTI-HBC LOM ABBOTT GERMANY 40408LI00

    Patients

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