BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 2182346 · Received July 28, 2011

    Report

    Report Number
    3002809144-2011-00530
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED AGAINST AN EX-US PRODUCT (B)(4) WHICH HAS A SIMILAR PRODUCT (B)(4) DISTRIBUTED IN THE US. A RETAINED KIT OF ARCHITECT ANTI-HBC II REAGENT, LIST NUMBER (B)(4), LOT NUMBER 93475HN00, WAS CALIBRATED AND THE CALIBRATION MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. THE CLINICAL SENSITIVITY WAS EVALUATED. REAGENT LOT 93475HN00 DETECTED ONE BLEED EARLIER (B)(6) AS THE DATA PROVIDED BY THE MANUFACTURER. AS PART OF THE EVALUATION THE COMPLAINT RECORDS FOR THE AFFECTED LOT NUMBER WERE REVIEWED AND DID NOT IDENTIFY ANY PROBLEMS RELATING TO THIS OBSERVATION. ALL GENERATED DATA DEMONSTRATE THAT THE PERFORMANCE OF THE ARCHITECT ANTI-HBC II REAGENT, LIST NUMBER (B)(4), LOT NUMBER 93475HN00, IS NOT COMPROMISED AND FULFILLS THE PACKAGE INSERT CLAIMS FOR SENSITIVITY. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    A FALSE (B)(6) RESULT FOR THE ARCHITECT ANTI-HBCII WAS GENERATED DURING THE INVESTIGATION OF A DIFFERENT ISSUE. THE ARCHITECT ANTI-HBCII WAS (B)(6) WITH LOT 93475HN00, (B)(6) WITH LOT 95625HN00. THE SAME SAMPLE WAS (B)(6) WITH THE AXSYM AND THE PRISM METHODS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER