BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 6687770 · Received July 5, 2017

    Report

    Report Number
    3002809144-2017-00107
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    June 9, 2017
    Report Date
    August 29, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: ADDITIONAL PATIENT TESTING PROVIDED. THE EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION TEAM REVIEWED THE PRODUCT HISTORY FOR ANY TRENDS RELATED TO THE ISSUE AND CUSTOMER COMPLAINTS RECEIVED FOR THE LOT TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THE CUSTOMER FACILITY. THE REVIEW CONCLUDED THAT SOME FURTHER COMPLAINTS REGARDING FALSE REACTIVE RESULTS FOR SINGLE PATIENT SAMPLES TESTED WITH LOT 71310LI00 (AND ASSOCIATED LOTS CONTAINING THE SAME BULK MATERIAL) WERE RECEIVED, BUT NO COMPLAINTS SO FAR FOR FALSE NON-REACTIVE PATIENT RESULTS WITH THIS LOT WERE RECEIVED. THE TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO RELATED ADVERSE TRENDS AND NON-STATISTICAL TRENDS IDENTIFIED FOR THE COMPLAINT ISSUE. A RETAINED KIT OF REAGENT LOT 71310LI00 WAS TESTED IN A SENSITIVITY SETUP. RESULTS OF THIS SETUP DID NOT IMPLICATE THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NEGATIVELY IMPACTED. THE REAGENT KIT SHOWED NORMAL PERFORMANCE WITHOUT FALSE NON-REACTIVE RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS. THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO TEST RESULTS PROVIDED BY THE COMMERCIAL MANUFACTURER AND THE ARCHITECT HIV AG/AB COMBO REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. A REVIEW OF THE OVERALL PERFORMANCE OF ARCHITECT HIV AG/AB COMBO REAGENT LOT 71310LI00 (AND ASSOCIATED LOTS) USED IN THE FIELD WAS GATHERED FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO THE CUT-OFF FOR THE NEGATIVE POPULATION AND THE MEDIAN OF THE POPULATIONS TESTED WITH THE LOT IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE VALUE OF OTHER ARCHITECT HIV AG/AB COMBO REAGENT LOTS. FURTHER THE REACTIVE RATE FOR BLOOD DONOR SAMPLES TESTED WITH THE LOT WAS REVIEWED. ASSUMING A ZERO PREVALENCE OF HIV INFECTION FOR THE SAMPLES TESTED WITHIN THE FIELD THE SPECIFICITY OF LOT 71310LI00 WOULD BE WITHIN PACKAGE INSERT SPECIFICATIONS. BASED ON FIELD DATA ANALYSIS IT WAS SHOWN THAT SPECIFICITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. TAKEN TOGETHER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT HIV AG/AB COMBO ASSAY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LIST NUMBER 4J27 THAT HAS SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2P36. THE EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    ADDITIONAL PATIENT TESTING WAS GENIUS CONFIRMATORY HIV-1/2 ANTIBODIES METHOD NONREACTIVE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED (B)(6) ARCHITECT HIV AG/AB COMBO RESULTS ON A PATIENT WITH PLASMA SAMPLES BUT (B)(6) WITH SERUM SAMPLES. INITIALLY, THE PATIENT TESTED ARCHITECT HIV AG/AB COMBO (B)(6). A NEW SERUM SPECIMEN WAS OBTAINED WITH (B)(6) ARCHITECT HIV AG/AB COMBO (B)(6) BUT PLASMA SPECIMEN (B)(6). THE SAMPLES WERE SENT TO ANOTHER LABORATORY (USING ARCHITECT I2000SR METHOD) WITH THE SAME RESULTS (B)(6) AND (B)(6). CONFIRMATORY TESTING IS PENDING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468719 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GERMANY 71310LI00

    Patients

    Seq Age Sex Outcome Treatment
    1