BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 6594827 · Received May 26, 2017

    Report

    Report Number
    3002809144-2017-00079
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    May 4, 2017
    Report Date
    August 28, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 8L44 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L22.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN INITIAL FALSE NON-REACTIVE RESULT FOR ONE PATIENT SAMPLE WHEN USING ARCHITECT ANTI-HBC II REAGENT, LIST NUMBER 8L44-35, LOT NUMBER 73144LI00. A REVIEW OF TICKETS FOR LOT 73144LI00 DID NOT IDENTIFY AN INCREASE IN COMPLAINTS AND NO TRENDS FOR THE REPORTED ISSUE. SENSITIVITY TESTING WAS PERFORMED WITH RETAINED KITS OF LOT 73144LI00 AND TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (BIOMEX SCP-HBV-001 AND SCP-HBV-004). THE SEROCONVERSION PANEL RESULTS WERE COMPARED WITH DATA PROVIDED BY BIOMEX. REAGENT LOT 73144LI00 DETECTED THE SAME BLEEDS AS REACTIVE WITH COMPARABLE S/CO VALUES WHEN COMPARED TO THE DATA PROVIDED BY BIOMEX. A REVIEW OF THE INSTRUMENT LOG FILES WAS PERFORMED AND DETECTED NO ISSUES ASSOCIATED WITH THIS COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. A REVIEW OF LABELING WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT ANTI-HBC II, LOT 73144LI00.

    Additional Manufacturer Narrative · 1

    CORRECTED SUSPECT MEDICAL DEVICE; LOT# FROM UNKNOWN TO 73144LI00.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) ARCHITECT (B)(6) ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID 6466568 ON (B)(6) 2017 INITIAL = 0.48S/CO (<1.00S/CO = (B)(6)) / REPEATED = 6.05S/CO (>/=1.00S/CO = (B)(6)). THE PATIENT WAS PREVIOUSLY (B)(6) FOR (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374545 ARCHITECT ANTI-HBC II ANTI-HBC LOM ABBOTT GERMANY 73144LI00

    Patients

    Seq Age Sex Outcome Treatment
    1