BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 2202659 · Received August 11, 2011

    Report

    Report Number
    3002809144-2011-00535
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    March 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REAGENT LOT 92447HN00 WAS NOT TESTED SINCE THE MATERIAL EXPIRED IN APRIL 2011. THREE (B)(6)SPECIMENS HAVE BEEN TESTED, WITH A RETAINED REAGENT KIT OF LOT 02023LI00 SHOWING NORMAL PERFORMANCE WITHOUT (B)(6) RESULTS. IN ADDITION TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HIV 9013 AND HIV 9016) WERE TESTED USING REAGENT LOT 02023LI00 TO ASSESS THE CLINICAL SENSITIVITY OF THE REAGENT LOT. THE OBTAINED RESULTS WERE COMPARED WITH ARCHITECT HIV AG/AB COMBO TEST DATA FROM THE MANUFACTURER (ZEPTOMETRIX) FOR THESE SEROCONVERSION PANELS. FOR PANEL 9016 REAGENT LOT 02023LI00 DETECTED THE SAME BLEEDS AS REACTIVE AS THE DATA FROM THE MANUFACTURER. FOR PANEL 9013, LOT 02023LI00 DETECTED EVEN ONE BLEED EARLIER AS REACTIVE AS THE DATA FROM THE MANUFACTURER. AS PART OF OUR EVALUATION WE HAVE REVIEWED THE COMPLAINT RECORDS FOR LOT NUMBER 92447HN00 AND 02023LI00. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER'S OBSERVATION. THERE ARE NO FURTHER COMPLAINTS FOR THESE LOTS REGARDING THIS ISSUE. BASED ON OUR EVALUATION, WE HAVE DETERMINED THAT ARCHITECT HIV AG/AB COMBO REAGENTS, LIST NUMBER 4J27-30, LOT NUMBERS 92447HN00 AND 02023LI00, IDENTIFIED IN THE CUSTOMER'S COMPLAINT, ARE PERFORMING ACCEPTABLY. ACCORDING TO THE CUSTOMER'S INFORMATION, THEY OBTAINED NON-REACTIVE RESULTS WITH THE ARCHITECT HIV COMBO FOR A SPECIMEN DRAWN IN (B)(6) 2011 AND A SPECIMEN FROM THE SAME PATIENT DRAWN IN (B)(6) 2011. THE SPECIMENS GAVE (B)(6) RESULTS WITH THE AXSYM HIV 1/2 GO ASSAY, WESTERN BLOT TESTING GAVE INDETERMINATE RESULTS AND PCR TESTING RESULTED IN (B)(6) RESULTS. SINCE MOST INDIVIDUALS PRODUCE DETECTABLE LEVELS OF ANTIBODY WITHIN 3 MONTHS OF INFECTION, THE INDETERMINATE RESULT OF THE WESTERN BLOTS MIGHT BE DUE TO UNSPECIFIC REACTIONS E.G. CROSS-REACTING ANTIBODIES FROM A VARIETY OF CONDITIONS AND THE SAME INTERFERENCE MAY CAUSE THE REACTIVE RESULT IN THE AXSYM HIV GO ASSAY. A FINAL CLASSIFICATION OF THE SAMPLE CANNOT BE MADE BASED ON THE CURRENTLY AVAILABLE DATA.

    Additional Manufacturer Narrative · 1

    THE RETURNED PATIENT SAMPLE WAS EVALUATED. THE SAMPLE WAS TESTED WITH A RETAINED REAGENT KIT OF THE ARCHITECT HIV AG/AB COMBO REAGENT, LIST NUMBER 4J27-30, LOT NUMBER 02023LI00. TESTING REVEALED A (B)(6) RESULT OF (B)(6), REPRODUCING THE CUSTOMER'S OBSERVATION. THE SAMPLE WAS NOT TESTED WITH REAGENT LOT 92447HN00 AS THIS MATERIAL WAS ALREADY EXPIRED IN APRIL 2011 AND RESULTS MAY NOT BE RELIABLE ANY MORE. WE PERFORMED ADDITIONAL REFERENCE TESTING OF THE SAMPLE AND OBTAINED THE FOLLOWING RESULTS: THE SAMPLE TESTED (B)(6) WITH THE AXSYM HIV AG/AB COMBO ASSAY ((B)(6)). THE SAMPLE TESTED (B)(6) WITH THE NEW LAV I BLOT (SIGNALS WERE DETECTED FOR (B)(6)). THE SAMPLE TESTED (B)(6) WITH THE NEW LAV II BLOT (SIGNALS WERE DETECTED FOR (B)(6)). THE SAMPLE TESTED (B)(6) WITH THE INNOTEST HIV MAB ((B)(6)). OUR EVALUATION OF THE SAMPLE REPRODUCES THE CUSTOMER'S OBTAINED RESULTS IN WHICH THE WESTERN BLOTS WERE INDETERMINATE AND THE AXSYM RESULT WAS (B)(6). UNFORTUNATELY, THERE IS NO CLEAR CONSISTENCY BETWEEN THESE RESULTS, THEREFORE, THE SAMPLE IS CLASSIFIED AS "UNABLE TO CATEGORIZE". SINCE OUR INITIAL EVALUATION WITH REGARDS TO THE REAGENT REVEALED THAT THERE IS NO GENERAL SENSITIVITY ISSUE FOR THE AFFECTED LOTS WE ASSUME THAT THERE MAY BE SOME UNSPECIFIC REACTIONS CAUSING THE (B)(6) WESTERN BLOT AND (B)(6) AXSYM RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4), ARCHITECT HIV AG/AB COMBO, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4), ARCHITECT HIV AG/AB COMBO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A POTENTIAL FALSE (B)(6) RESULT WAS GENERATED ON THE ARCHITECT HIV AG/AB COMBO ASSAY. IN MID (B)(6) 2011, A BLOOD BAG WAS TESTED AT ANOTHER FACILITY (HOSPITAL) AND WAS (B)(6) ON THE AXSYM HIV ASSAY. THE BAG WAS RETESTED AT THE CUSTOMER'S FACILITY AND YIELDED A (B)(6) RESULT OF (B)(6) ON THE ARCHITECT HIV AG/AB COMBO ASSAY. WESTERN BLOT TESTING WAS INDETERMINATE AND WAS (B)(6). A FRESH SAMPLE WAS TESTED AT THE HOSPITAL AND WAS (B)(6) ON AXSYM HIV BUT WHEN THE CUSTOMER TESTED THE SAMPLE AT THEIR FACILITY, THE RESULT WAS (B)(6) ON THE ARCHITECT. FINAL RESULTS FOR HIV RNA TESTING WAS (B)(6). ON (B)(6) 2011, THIS PATIENT WAS TESTED FOR HIV RNA AND THE RESULT WAS (B)(6). THE PATIENT SPECIMEN WAS INDETERMINATE ON WESTERN BLOT, (B)(6). THE CUSTOMER IS QUESTIONING THE (B)(6) ARCHITECT RESULTS GIVEN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HIV AG/AB COMBO MZF ABBOTT GERMANY 92447HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 LIST # 8C89-88 SERIAL # (B)(4)| ARCHITECT I2000 LIST # 8C89-88 SERIAL # (B)(4)| ARCHITECT I2000 LIST #8C89-88 SERIAL # (B)(4)