BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTI HIV-1/HIV-2 ANTIBODY TEST

    MDR report key: 18376404 · Received December 21, 2023

    Report

    Report Number
    3003871407-2023-00003
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    October 27, 2023
    Report Date
    February 10, 2025
    Manufacturer
    BIOLYTICAL LABORTORIES INC
    Product Code
    QSU
    UDI-DI
    00686597010198
    PMA / PMN Number
    BP090032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: COASTAL BEND WELLNESS FOUNDATION IN TEXAS, USA REPORTED 2 X FALSE NEGATIVE (FN) RESULTS USING THE INSTI HIV-1/HIV-2 ANTIBODY TEST FROM KIT LOT 1019230157 ON (B)(6) 2023, FROM TWO INDIVIDUAL PATIENTS WITH FINGERSTICK BLOOD SAMPLES. BOTH PATIENTS TESTED POSITIVE FOR HIV AT THE PLASMA DONATION AND WERE REPORTED TO THE LOCAL HEALTH DEPARTMENT. INFORMATION AVAILABLE FOR BOTH PATIENTS: ON (B)(6) 2023, PATIENT#1 TESTED NEGATIVE FOR HIV USING INSTI, HOWEVER HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6), 2023. ON (B)(6) 2023, PATIENT#2 TESTED NEGATIVE FOR HIV USING INSTI, HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. THE CUSTOMER HAS TESTED THE INSTI CONTROLS TO MAKE SURE THE TEST KITS WORKING, THE TEST RESULTS WERE AS EXPECTED, AND IT WAS CONFIRMED THAT THE KITS ARE STORED AS PER THE IFU. THE CUSTOMER PROVIDED NO PICTURES OF THE FALSE NEGATIVE RESULTS WITH INSTI. ADDITIONAL INFORMATION: ONLY SIX (6) REMAINING TESTS FROM KIT LOT 1019230157 ARE AVAILABLE ON-SITE, THEREFORE BIOLYTICAL WAS NOT ABLE TO REQUEST THE TEST KITS THAT WERE STORED FROM THE SITE FOR RETURNED KIT ANALYSIS. IT WAS CONFIRMED THAT PATIENTS HAD NOT GONE THROUGH ANY ART PROCEDURE PRIOR TO TESTING IT ON INSTI BUT LINKED TO RELATIONSHIPS WITH PATIENTS WHO HAD PREVIOUSLY HIV POSITIVES. BIOLYTICAL INQUIRED WITH THE CLINIC IF THEY HAD AVAILABLE STORED SERUM OR PLASMA SAMPLES OF THE TWO PATIENTS TO REPEAT THE TESTING WITH DIFFERENT LOTS OF INSTI, AND IT WAS CONFIRMED THERE WERE NO STORED SAMPLES. BIOLYTICAL INVESTIGATION SUMMARY: AN INVESTIGATION OF KIT LOT 1019230157 WAS CARRIED OUT BY REVIEWING OF THE PRODUCTION BATCH RECORDS AND PERFORMING TESTING USING RETENTION KITS RELATED TO INSTI KIT LOT 1019230157. PRODUCTION BATCH RECORD REVIEW: ALL THE MANUFACTURING AND QUALITY CONTROL DOCUMENTATION WAS REVIEWED FOR KIT LOT 1019230157. ALL TEST COMPONENTS PASSED ESSENTIAL QC INSPECTIONS AND RELEVANT PRODUCTION RECORDS DID NOT SHOW ANY NON-CONFORMITIES. RETENTION KIT TESTING: TESTING WAS CARRIED OUT ON QC RETENTION KIT LOT 1019230157, ALL TESTING RESULTS WERE AS EXPECTED. THERE WERE NO PREVIOUS PERFORMANCE-RELATED CUSTOMER COMPLAINTS REPORTED FOR THE IDENTIFIED INSTI HIV KIT LOT 1019230157. RETENTION TESTING RESULTS FOR ALL RETAINED COMPONENTS WERE AS EXPECTED, AND THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED. TREND ANALYSIS: TREND ANALYSIS WAS ALSO CONDUCTED FOR THE SPECIFIC MATCH LOT (MU23039) AND THE OVERALL INSTI HIV-1/HIV-2 ANTIBODY TEST KIT IN RELATION TO FALSE NEGATIVE ISSUES AND THERE WERE NO REPORTABLE TRENDS OBSERVED FOR BOTH AND NO OTHER COMPLAINTS RECEIVED FOR THIS SPECIFIC LOTS. CAPA CONSIDERATION: CAPA IS NOT WARRANTED AT THIS TIME AS THERE IS NO TREND OF FALSE NEGATIVE RESULTS OBSERVED. DURING THE BIOLYTICAL INTERNAL INVESTIGATION, ALL RESULTS WERE AS EXPECTED; THE ROOT CAUSE IS UNDETERMINED. AS THERE IS NO MALFUNCTION OR ADVERSE EFFECT ASSOCIATED WITH THIS COMPLAINT, CAPA IS NOT REQUIRED AT THIS TIME. CONCLUSION: BASED ON THE INTERNAL INVESTIGATION, NEITHER ANY NON-CONFORMITIES NOR PREVIOUS PERFORMANCE-RELATED CUSTOMER COMPLAINTS WERE REPORTED FOR THE IDENTIFIED INSTI HIV KIT LOT 1019230157, ITS MATCH LOT (MU23039), AND THE CORRESPONDING CRITICAL COMPONENTS (BMU OR COLOUR DEVELOPER). TREND ANALYSIS WAS ALSO CONDUCTED FOR THIS SPECIFIC MATCH LOT (MU23010) AND THE OVERALL INSTI HIV-1/HIV-2 ANTIBODY TEST KIT IN RELATION TO FALSE NEGATIVE ISSUES AND THERE WERE NO REPORTABLE TRENDS OBSERVED FOR BOTH. THEREFORE, THE ROOT CAUSE FOR THIS COMPLAINT IS UNDETERMINED. INSTI HIV 1/2 ANTIBODY TEST IS INTENDED FOR USE AS AN AID-IN-DIAGNOSIS KIT ONLY AND NOT A CONFIRMATORY TEST. THE PERFORMANCE OF THE INSTI HIV KIT LOT 1019230157 WILL BE CONTINUOUSLY MONITORED THROUGH POST-MARKET SURVEILLANCE ACTIVITIES THROUGHOUT THE YEAR. THIS IS A COMBINED INITIAL AND FINAL REPORT, NO FOLLOW UP REPORT WILL BE SUBMITTED UNLESS REQUESTED BY THE FDA.

    Additional Manufacturer Narrative · 0

    "UDI RELATED DATA QUALITY UPDATES ONLY" UPON REVIEW OF THE EMAIL FROM FDA RECEIVED ON 13TH DECEMBER 2024 IN RELATION TO MDR#3003871407-2023-00003, BIOLYTICAL IDENTIFIED THAT A FULL UDI WAS NOT PROVIDED IN THE MDR FORM#3003871407-2023-00003 THAT WAS SUBMITTED TO FDA ON 21ST DECEMBER 2023, BUT ONLY THE DEVICE IDENTIFIER (DI) WAS RECORDED. BIOLYTICAL HAS SINCE CORRECTED THE MDR FORM TO INCLUDE FULL UDI WHICH INCLUDES DI + PRODUCTION IDENTIFIER AND THIS SUPPLEMENTAL REPORT FOR MDR# 3003871407-2023-00003 IS BEING SUBMITTED TO ADDRESS THE UDI DISCREPANCY.

    Description of Event or Problem · 0

    COASTAL BEND WELLNESS FOUNDATION IN TEXAS, USA REPORTED 2 X FALSE NEGATIVE (FN) RESULTS USING THE INSTI HIV-1/HIV-2 ANTIBODY TEST FROM KIT LOT 1019230157 ON (B)(6) 2023, FROM TWO INDIVIDUAL PATIENTS WITH FINGERSTICK BLOOD SAMPLES. BOTH PATIENTS TESTED POSITIVE FOR HIV AT THE PLASMA DONATION AND WERE REPORTED TO THE LOCAL HEALTH DEPARTMENT. INFORMATION AVAILABLE FOR BOTH PATIENTS: ON (B)(6), 2023, PATIENT#1 TESTED NEGATIVE FOR HIV USING INSTI, HOWEVER HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. ON (B)(6), 2023, PATIENT#2 TESTED NEGATIVE FOR HIV USING INSTI, HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. THE CUSTOMER HAS TESTED THE INSTI CONTROLS TO MAKE SURE THE TEST KITS WORKING, THE TEST RESULTS WERE AS EXPECTED, AND IT WAS CONFIRMED THAT THE KITS ARE STORED AS PER THE IFU. THE CUSTOMER PROVIDED NO PICTURES OF THE FALSE NEGATIVE RESULTS WITH INSTI.

    Description of Event or Problem · 0

    COASTAL BEND WELLNESS FOUNDATION IN TEXAS, USA REPORTED 2 X FALSE NEGATIVE (FN) RESULTS USING THE INSTI HIV-1/HIV-2 ANTIBODY TEST FROM KIT LOT 1019230157 ON (B)(6) 2023, FROM TWO INDIVIDUAL PATIENTS WITH FINGERSTICK BLOOD SAMPLES. BOTH PATIENTS TESTED POSITIVE FOR HIV AT THE PLASMA DONATION AND WERE REPORTED TO THE LOCAL HEALTH DEPARTMENT. INFORMATION AVAILABLE FOR BOTH PATIENTS: ON (B)(6) 2023, PATIENT#1 TESTED NEGATIVE FOR HIV USING INSTI, HOWEVER HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. ON (B)(6) 2023, PATIENT#2 TESTED NEGATIVE FOR HIV USING INSTI, HIV 1/2 4TH GEN, RFLX CON (ROCHE COBAS ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA) RESULT WAS HIV-1 REACTIVE ON (B)(6) 2023. THE CUSTOMER HAS TESTED THE INSTI CONTROLS TO MAKE SURE THE TEST KITS WORKING, THE TEST RESULTS WERE AS EXPECTED, AND IT WAS CONFIRMED THAT THE KITS ARE STORED AS PER THE IFU. THE CUSTOMER PROVIDED NO PICTURES OF THE FALSE NEGATIVE RESULTS WITH INSTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298328 INSTI HIV-1/HIV-2 ANTIBODY TEST INSTI HIV TEST QSU BIOLYTICAL LABORTORIES INC 90-1019 1019230157 00686597010198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other