BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTI HIV-1/HIV-2 ANTIBODY TEST

    MDR report key: 7664085 · Received July 5, 2018

    Report

    Report Number
    3003871407-2018-00003
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    June 18, 2018
    Manufacturer
    BIOLYTICAL LABORATORIES INC.
    Product Code
    MZF
    PMA / PMN Number
    BP090032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS CONDUCTED UNDER (B)(4). INVESTIGATION WAS DONE ON INSTI HIV TEST KITS FROM LOT 1702BB003 THAT WERE RETAINED AT BIOLYTICAL AND ALSO ON 2X INSTI HIV TEST KITS FROM LOT 1702BB003 RETURNED BY THE CUSTOMER ((B)(6) CENTRE). RESULTS OF THE INTERNAL INVESTIGATION SHOW THAT THE TEST KITS PERFORMED AS EXPECTED. THERE WAS NO MALFUNCTIONING IDENTIFIED WITH THESE KITS. IT WAS THEREFORE CONCLUDED THAT THE (B)(6) TEST RESULT SEEN WITH ONE PATIENT WAS RELATED TO THE PATIENT SAMPLE TYPE. THE PATIENT SAMPLE INVOLVED IN THIS COMPLAINT IS OF A SUPER ELITE CONTROLLER. THIS SUPER ELITE CONTROLLER IS AN EXTREMELY RARE CASE AND WILL NOT IMPACT OUR PERFORMANCE CLAIMS. MORE INFORMATION ON SUPER ELITE CONTROLLERS IS PROVIDED BELOW. SUPER ELITE CONTROLLER INFORMATION LONG-TERM NON-PROGRESSORS (LTNPS), SOMETIMES ALSO CALLED "ELITE CONTROLLERS", ARE INDIVIDUALS INFECTED WITH (B)(6), WHO MAINTAIN A CD4 COUNT GREATER THAN 500 WITHOUT ANTIRETROVIRAL THERAPY WITH A DETECTABLE VIRAL LOAD. MANY OF THESE PATIENTS HAVE BEEN (B)(6) FOR 30 YEARS WITHOUT PROGRESSING TO THE POINT OF NEEDING TO TAKE MEDICATION IN ORDER NOT TO DEVELOP (B)(6). THE CLASSIFICATION "LONG-TERM NON-PROGRESSOR" IS NOT PERMANENT, BECAUSE SOME PATIENTS IN THIS CATEGORY HAVE GONE ON TO DEVELOP (B)(6). LONG-TERM NON-PROGRESSORS TYPICALLY HAVE VIRAL LOADS UNDER 10,000 COPIES RNA/ML BLOOD, DO NOT TAKE ANTIRETROVIRALS, AND HAVE CD4+ COUNTS WITHIN THE NORMAL RANGE. MOST PEOPLE WITH (B)(6) NOT ON MEDICATION HAVE VIRAL LOADS WHICH ARE MUCH HIGHER. IT IS ESTIMATED THAT AROUND 1 IN 300 PEOPLE WITH (B)(6) ARE LONG-TERM NON-PROGRESSORS. WITHOUT THE SYMPTOMS OF (B)(6), MANY LTNP PATIENTS MAY NOT KNOW THEY ARE INFECTED. IN SEARCHING THE LITERATURE(1), ONE STUDY OF 29 ELITE CONTROLLERS DID SHOW THAT 21/29 HAD DETECTABLE PROVIRAL DNA, BUT 8/29 WERE DNA (B)(6), THUS IT IS POSSIBLE TO BE PROVIRAL DNA (B)(6). THIS CCR CASE IS A TRUE ELITE CONTROLLER, INFECTED WITH (B)(6) BUT ABLE TO KEEP THE VIRUS FULLY SUPPRESSED THROUGH THEIR OWN IMMUNE SYSTEM, AND IS ONE THAT INSTI IS (B)(6) FOR, ALONG WITH OTHER MARKERS IN THE TOTAL RESULTS PROFILE. THIS IS AN EXTREMELY RARE CASE. REFERENCE: CLINICAL INFECTIOUS DISEASES, VOLUME 51, ISSUE 2, 15 JULY 2010. THIS COMPLAINT IS BEING REPORTED AS A FOREIGN EVENT. THE INSTI HIV TEST KIT LOT 1702BB003 WAS NOT DISTRIBUTED IN THE U.S. THE COMPLAINT OCCURED IN THE (B)(6) AND IS REPORTED TO FDA RETROSPECTIVELY AS A FOREIGN EVENT. NO REMEDIAL ACTION WAS REQUIRED.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED TO FDA AS A FOREIGN EVENT. THE COMPLAINT OCCURED IN THE (B)(6) AND WAS REPORTED TO THE (B)(6). ONE (B)(6) CENTER USED INSTI HIV-1/HIV-2 ANTIBODY TEST ON A MALE PATIENT AND OBSERVED (B)(6) RESULT. THE PATIENT HOWEVER TESTED (B)(6) WITH A LABORATORY BASED 5TH GENERATION HIV TEST AS CONFIRMED BY THE (B)(6) LABORATORY IN (B)(6). THE (B)(6) CENTRE DOES NOT THINK THIS IS AN OPERATOR ERROR. THE GENTLEMAN IN QUESTION IS A SUPER ELITE CONTROLLER WITH AN UNDETECTABLE HIV-1 VIRAL LOAD. BIOLYTICAL (THE MANUFACTURER) REQUESTED PATIENT SAMPLES AND SAMPLE TEST KITS FROM THE (B)(6) CENTRE FOR CONDUCTING INTERNAL INVESTIGATION. TWO INSTI HIV TEST KITS FROM LOT 1702BB003 WERE RETURNED TO BIOLYTICAL FOR INVESTIGATION. PATIENT SAMPLE WAS NOT PROVIDED TO BIOLYTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507186 INSTI HIV-1/HIV-2 ANTIBODY TEST INSTI HIV-1/HIV-2 ANTIBODY TEST MZF BIOLYTICAL LABORATORIES INC. 90-1015 1702BB003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other