BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 15962437 · Received December 12, 2022

    Report

    Report Number
    3002809144-2022-00434
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 24, 2022
    Report Date
    February 14, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER = SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NON-REACTIVE RESULTS WHEN TESTING A KNOWN HIV PATIENT WITH ALINITY I HIV AG/AB COMBO REAGENT, LOT NUMBER 41177BE00 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING OF THE COMPLAINT LOT AND ADDITIONAL LOT USED IN TROUBLESHOOTING BY ABBOTT FIELD AT A DIFFERENT LABORATORY, 43432BE00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 41177BE00 AND THE COMPLAINT ISSUE. IN-HOUSE TESTING OF RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED AND LOT USED IN TROUBLESHOOTING, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HIV 9013 AND HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV TEST RESULTS PROVIDED BY ZEPTOMETRIX. REAGENT LOT 43432BE00 DETECTS THE SAME FIRST REACTIVE BLEED AS MANUFACTURERS DATA FOR BOTH PANELS. REAGENT LOT 41177BE00 DETECTS ONE BLEED EARLIER FOR SEROCONVERSION PANEL 9013 AND FOR PANEL 9016 THE SAME FIRST REACTIVE BLEED AS MANUFACTURERS DATA. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH ALINITY I HIV AG/AB COMBO REAGENT, LOT NUMBER 41177BE00 WAS IDENTIFIED. CORRECTED H10 TO CORRECT PRODUCT DESCRIPTION IN LAST SENTENCE FROM BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH ARCHITECT SYPHILIS TP REAGENT, LOT NUMBER 41177BE00 WAS IDENTIFIED TO CORRECT BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH ALINITY I HIV AG/AB COMBO REAGENT, LOT NUMBER 41177BE00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NON-REACTIVE RESULTS WHEN TESTING A KNOWN HIV PATIENT WITH ALINITY I HIV AG/AB COMBO REAGENT, LOT NUMBER 41177BE00 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING OF THE COMPLAINT LOT AND ADDITIONAL LOT USED IN TROUBLESHOOTING BY ABBOTT FIELD AT A DIFFERENT LABORATORY, 43432BE00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 41177BE00 AND THE COMPLAINT ISSUE. IN-HOUSE TESTING OF RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED AND LOT USED IN TROUBLESHOOTING, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HIV 9013 AND HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV TEST RESULTS PROVIDED BY ZEPTOMETRIX. REAGENT LOT 43432BE00 DETECTS THE SAME FIRST REACTIVE BLEED AS MANUFACTURERS DATA FOR BOTH PANELS. REAGENT LOT 41177BE00 DETECTS ONE BLEED EARLIER FOR SEROCONVERSION PANEL 9013 AND FOR PANEL 9016 THE SAME FIRST REACTIVE BLEED AS MANUFACTURERS DATA. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH ARCHITECT SYPHILIS TP REAGENT, LOT NUMBER 41177BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULT FOR A KNOWN HIV POSITIVE 5 YEAR OLD FEMALE PATIENT WITH A BENIGN HEAD TUMOR. THE FOLLOWING DATA WAS PROVIDED: RESULT FROM (B)(6) 2022 SID (B)(6) ALINITY = 0.37 S/CO = NEGATIVE, REPEATED RESULT ON (B)(6) 2022 SID (B)(6) = 0.47 S/CO ANOTHER ALINITY IN SAME LAB = 0.40 S/CO CUTOFF(>=1.00 S/CO) HIV RAPID TEST STRIP = REACTIVE. HIV DETERMINE STRIP = REACTIVE. RESULT FROM (B)(6) 2022 BIOMERIEUX VIDAS HIV AB = 6.33 TV (REFERENCE < 0.25) RESULT FROM (B)(6) 2022 BIOMERIEUX VIDAS HIV AG = NOT DETERMINABLE RESULT FROM (B)(6) 2022 ABBOTT VIRAL LOAD DETECTED = 144(CUTOFF IS 10 COPIES/ML) RESULT FROM (B)(6) 2022 BIORAD GEENIUS LINE IMMUNE BLOT = REACTIVE FOR BANDS 4 AND 6(GP160 : 1+ GP41 : 2+ VISIBLE LINE) DETAILS OF BIORAD GENIUS RESULTS: BAND INFORMATION OF BIORAD GEENIUS AS BELOW, BAND 1: GP36 (HIV-2, ENVELOP PEPTIDE) HIV-2 ENV, BAND 2: GP140 (HIV-2, ENVELOP PEPTIDES) HIV-2 ENV, BAND 3: P31 (HIV-1, POLYMERASE PEPTIDE) HIV-1 POL, BAND 4: GP160 (HIV-1, ENVELOP RECOMBINANT PROTEIN) HIV-1 ENV, BAND 5: P24 (HIV-1, CORE RECOMBINANT PROTEIN) HIV-1 GAG, BAND 6: GP41 (GROUP M AND O) (HIV-1, ENVELOP PEPTIDES) HIV-1 ENV, CTRL BAND: PROTEIN A. THE FOLLOWING RESULTS ARE FROM (B)(6) 2022 AND SID (B)(6): WONFO 3RD GEN AB = REACTIVE VISIBLE LINE, DETERMINE 3RD GEN AB = REACTIVE WEAKLY VISIBLE LINE, ROCHE HIV DUO AG = 6.31 COI = REACTIVE (CUTOFF <0.9 COI), ROCHE HIV DUO AB = 14.00 COI = REACTIVE (CUTOFF < 0.9 COI), ROCHE HIV DUO AG/AB = 15.4 COI = REACTIVE (CUTOFF <0.9COI), RESULT FROM 23NOV2022 OTHER LAB ARCHITECT HIV AG/AB COMBO(RAN FOR TROUBLESHOOTING ONLY) = NONREACTIVE 0.83 CUTOFF(>=1.00 S/CO), RESULT FROM (B)(6) 2022 OTHER LAB ALINITY HIV AG/AB COMBO(RAN FOR TROUBLESHOOTING ONLY)= NONREACTIVE 0.7 CUTOFF(>=1.00 S/CO), RESULT FROM 28NOV2022 SID 2214274091 ABBOTT VIRAL LOAD DETECTED 120,000 CUTOFF = 10 COPIES/ML. THE FOLLOWING RESULTS ARE FROM (B)(6) 2022: ALINITY HIV AG/AB COMBO REACTIVE 1.85 CUTOFF (>=1.00 S/CO), DETERMINE 3RD GEN AB REACTIVE, WONFO 3RD GEN AB REACTIVE, BIOMERIEUX VIDAS HIV DUO ULTRA AG = NOT DETERMINABLE AB = REACTIVE 8.02, ROCHE DUO AG = REACTIVE 24.7 AB = REACTIVE 21.9 DUO = 33 (CUTOFF <0.9COI), ADDITIONAL INFORMATION FROM NEW BLEED ON 7 DECEMBER 2022: ALINITY HIV AG/AB COMBO NEGATIVE 0.65 (>=1.00 S/CO = REACTIVE), ROCHE DUO AG NEGATIVE 0.24 (< 0.9 = NON-REACTIVE), AB REACTIVE 41.3 (< 0.9 = NON-REACTIVE), DUO 41.3 (< 0.9 = NON-REACTIVE), DETERMINE 3RD GEN. AB REACTIVE, WONFO 3RD GEN. AB REACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULT FOR A KNOWN HIV POSITIVE 5 YEAR OLD FEMALE PATIENT WITH A HEAD TUMOR, AND LIMB WEAKNESS, NOTE IN CHART FROM (B)(6) SUSPECTED LYMPHOMA START CHEMORX (LYMPHOMA REGIMEN: CYCLOPHOSPHAMIDE, VINCRISTINE AND PREDNISOLONE) 1 COURSE THEN CONTINUE PREDNISOLONE UNTIL (B)(6) 2022. THE FOLLOWING DATA WAS PROVIDED: RESULT FROM (B)(6) 2022. SID: (B)(6). ALINITY = 0.37 S/CO = NEGATIVE, REPEATED RESULT ON (B)(6) 2022. SID (B)(6). = 0.47 S/CO ANOTHER ALINITY IN SAME LAB = 0.40 S/CO CUTOFF(>=1.00 S/CO). HIV RAPID TEST STRIP = REACTIVE. HIV DETERMINE STRIP = REACTIVE. RESULT FROM (B)(6) 2022 BIOMERIEUX VIDAS HIV AB = 6.33 TV (REFERENCE < 0.25). RESULT FROM (B)(6) 2022 BIOMERIEUX VIDAS HIV AG = NOT DETERMINABLE. RESULT FROM (B)(6) 2022 ABBOTT VIRAL LOAD DETECTED = 144(CUTOFF IS 10 COPIES/ML). RESULT FROM (B)(6) 2022 BIORAD GEENIUS LINE IMMUNE BLOT = REACTIVE FOR BANDS 4 AND 6(GP160 : 1+ GP41 : 2+ VISIBLE LINE). DETAILS OF BIORAD GENIUS RESULTS: BAND INFORMATION OF BIORAD GEENIUS AS BELOW. BAND 1: GP36 (HIV-2, ENVELOP PEPTIDE) HIV-2 ENV. BAND 2: GP140 (HIV-2, ENVELOP PEPTIDES) HIV-2 ENV. BAND 3: P31 (HIV-1, POLYMERASE PEPTIDE) HIV-1 POL. BAND 4: GP160 (HIV-1, ENVELOP RECOMBINANT PROTEIN) HIV-1 ENV. BAND 5: P24 (HIV-1, CORE RECOMBINANT PROTEIN) HIV-1 GAG. BAND 6: GP41 (GROUP M AND O) (HIV-1, ENVELOP PEPTIDES) HIV-1 ENV. CTRL BAND: PROTEIN A. THE FOLLOWING RESULTS ARE FROM (B)(6) 2022 AND SID (B)(6) : WONFO 3RD GEN AB = REACTIVE VISIBLE LINE. DETERMINE 3RD GEN AB = REACTIVE WEAKLY VISIBLE LINE. ROCHE HIV DUO AG = 6.31 COI = REACTIVE (CUTOFF <0.9 COI). ROCHE HIV DUO AB = 14.00 COI = REACTIVE (CUTOFF < 0.9 COI). ROCHE HIV DUO AG/AB = 15.4 COI = REACTIVE (CUTOFF <0.9COI). RESULT FROM (B)(6) 2022 OTHER LAB ARCHITECT HIV AG/AB COMBO(RAN FOR TROUBLESHOOTING ONLY) = NONREACTIVE 0.83 CUTOFF(>=1.00 S/CO). RESULT FROM (B)(6) 2022 OTHER LAB ALINITY HIV AG/AB COMBO(RAN FOR TROUBLESHOOTING ONLY)= NONREACTIVE 0.7 CUTOFF(>=1.00 S/CO). RESULT FROM (B)(6) 2022 SID (B)(6). ABBOTT VIRAL LOAD DETECTED 120,000 CUTOFF = 10 COPIES/ML THE FOLLOWING RESULTS ARE FROM (B)(6) 2022: ALINITY HIV AG/AB COMBO REACTIVE 1.85 CUTOFF (>=1.00 S/CO). DETERMINE 3RD GEN AB REACTIVE. WONFO 3RD GEN AB REACTIVE. BIOMERIEUX VIDAS HIV DUO ULTRA AG = NOT DETERMINABLE AB = REACTIVE 8.02 ROCHE DUO AG = REACTIVE 24.7 AB = REACTIVE 21.9 DUO = 33 (CUTOFF <0.9COI). ADDITIONAL INFORMATION FROM NEW BLEED ON (B)(6) 2022: ALINITY HIV AG/AB COMBO NEGATIVE 0.65 (>=1.00 S/CO = REACTIVE). ROCHE DUO AG NEGATIVE 0.24 (< 0.9 = NON-REACTIVE). AB REACTIVE 41.3 (< 0.9 = NON-REACTIVE). DUO 41.3 (< 0.9 = NON-REACTIVE). DETERMINE 3RD GEN. AB REACTIVE. WONFO 3RD GEN. AB REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503332 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 41177BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)