BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 6034576 · Received October 17, 2016

    Report

    Report Number
    3002809144-2016-00089
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Report Date
    June 2, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GV
    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 04J27, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02P36.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.

    Additional Manufacturer Narrative · 1

    AN IN-HOUSE RETAINED ARCHITECT HIV AG/AB COMBO ASSAY REAGENT KIT OF LOT NUMBER 62306LI00 (ACTUAL LOT USED WAS NOT PROVIDED BY THE CUSTOMER) WAS TESTED IN A SENSITIVITY SETUP (NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE). RESULTS DID NOT IMPLICATE THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NEGATIVELY IMPACTED. THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS. THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV TEST RESULTS PROVIDED BY THE MANUFACTURER. THE REAGENT DETECTED THE SAME BLEEDS AS (B)(6) FOR THE SEROCONVERSION PANELS. BASED ON THE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF REAGENT LOT 62306LI00 IS NOT ADVERSELY AFFECTED AND IS PERFORMING WITHIN SPECIFICATIONS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT HIV AG/AB COMBO ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO CONCLUDE ON A TRUE RESULT. NO CLINICAL DATA OR PATIENT HISTORY WAS PROVIDED TO CONCLUDE ON AN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT ONE DONOR SAMPLE GENERATED (B)(6) RESULTS WITH THE ARCHITECT (B)(6) COMBO, (B)(6) ASSAYS AND (B)(6) RESULTS WITH THE ARCHITECT SYPHILIS TP ASSAY. THE SAMPLE WAS SENT TO TWO OTHER LABS AND TESTED (B)(6) WITH THE IMMUNOCOMBO (B)(6) BISPOT METHODOLOGY. THE FOLLOWING WAS PROVIDED BY THE CUSTOMER: (B)(6). ALL OF THE ABOVE RESULTS WERE TAKEN FROM THE SAME DONOR DRAW. THE DONOR UNIT WAS NOT USED FOR ANY MEDICAL TREATMENT. THE DONOR DID NOT HAVE ANY SYMPTOMS OF AN HIV INFECTION. VIRAL LOAD TESTING FOUND NO VIRUS DETECTED. DETERMINE METHODOLOGY RESULTS WERE INVALID ((B)(6) WITH DILUENT AND (B)(6) WITHOUT DILUENT) AND PCR TESTING IS (B)(6). ON (B)(6) 2016: A DIFFERENT LOT OF THE ARCHITECT (B)(6) COMBO ASSAY WAS USED TO TEST THIS PATIENT AND RESULTS WERE (B)(6). NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING LOT/LIST NUMBERS FOR THIS SECOND LOT. THERE IS NO FURTHER IMPACT TO DONOR MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685589 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES, MZF ABBOTT GERMANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 SN: (B)(4)