BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 5075011 · Received September 14, 2015

    Report

    Report Number
    3002809144-2015-00063
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    May 29, 2015
    Report Date
    September 14, 2015
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04J27 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02P36. (B)(4). FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF PRODUCT LABELING. RETURN MATERIAL WAS NOT AVAILABLE. A CLINICAL SPECIFICITY TESTING PROTOCOL WAS EXECUTED USING THE ARCHITECT HIV AG/AB COMBO ASSAY. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE THE PRODUCT IS MEETING EXPECTED SPECIFICITY REQUIREMENTS AND IS PERFORMING ACCEPTABLY. NO ISSUES WERE IDENTIFIED FROM THE BATCH RECORD REVIEW WHICH WOULD INDICATE A PRODUCT DEFICIENCY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT HIV AG/AB COMBO ASSAY, LIST NUMBER 04J27, LOT 48502LI00 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT HIV AG/AB COMBO RESULTS FOR ONE PATIENT. THE CUSTOMER INDICATED A NON REACTIVE RESULT OF 0.39 S/CO ON (B)(6) 2015 COMPARED TO REACTIVE RESULTS GENERATED ON (B)(6), 2015 (4.95) AND (B)(6), 2015 ( 6.10, 5.66 AND 5.70). ADDITIONALLY, THE PATIENT TESTED REACTIVE USING THE DIASORIN AND WESTERN BLOT METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605748 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GERMANY 48502LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening