BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 3782163 · Received April 30, 2014

    Report

    Report Number
    3002809144-2014-00125
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE PATIENT IDENTIFIER IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT HIV AG/AB COMBO LIST 04J27, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, ARCHITECT HIV AG/AB COMBO LIST 02P36. NO CONSEQUENCES OR IMPACT TO PATIENT. FALSE NEGATIVE RESULT. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Additional Manufacturer Narrative · 1

    NO CUSTOMER RETURNS WERE RECEIVED FOR EVALUATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. A RETAINED KIT OF ARCHITECT (B)(6) REAGENT LOT NUMBER 33296LI00 WAS TESTED AND ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. IN ADDITION, THE CLINICAL SENSITIVITY OF THE AFFECTED LOT WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS. THE REAGENT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THIS DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE IS NOT ADVERSELY AFFECTED. TICKET SEARCHES DETERMINED THAT THERE IS NO ATYPICAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. THE TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO RELATED ADVERSE TRENDS AND NO NON-STATISTICAL TRENDS IDENTIFIED FOR THE COMPLAINT ISSUE. ALL TOGETHER, BASED ON THIS EVALUATION, THE PRODUCT IS PERFORMING AS INTENDED AND NO PRODUCT ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT QUESTIONED NONREACTIVE ARCHITECT HIV AG/AB COMBO RESULTS OF (B)(6) ON A PATIENT SAMPLE (ID (B)(6)) THAT TESTED ROCHE MODULAR HIV COMBO (B)(6) OF (B)(6). WESTERN BLOT TESTING WAS NEGATIVE FOR ALL BANDS. ADDITIONALLY, THE PATIENT HAS NO CLINICAL HISTORY AND TESTED ROCHE MODULAR HBSAG NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260060 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GERMANY 33296LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR ARCHITECT I2000SR LIST 03M74-01| SERIAL (B)(4)| ARCHITECT I2000SR LIST 03M74-01| SERIAL (B)(4)