BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HIV AG/AB COMBO REAGENT KIT

    MDR report key: 13064065 · Received December 22, 2021

    Report

    Report Number
    3002809144-2021-00714
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    December 1, 2021
    Report Date
    March 28, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117184
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION 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 CUSTOMER DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET AND TRENDING REVIEW DETERMINED NO TRENDS FOR THE LIKELY CAUSE LOT OR COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. A CUSTOMER DATA REVIEW FOR ALINITY S HIV AG/AB COMBO, LN 6P01-60, LOT 24562BE00 WAS PERFORMED. THE ANALYSIS INCLUDED INITIAL REACTIVE RATES (IRR), REPEAT REACTIVE RATES (RRR) AND SPECIFICITY (ASSUMING ZERO PREVALENCE) AT MID AMERICA TRANSPLANT SVC (MATS), CADAVERIC PEER SITES AND ACROSS ALL CUSTOMER SITES USING THIS LOT. THE SPECIFICITY AND REACTIVE RATE PERFORMANCE OF LOT 24562BE00 AT MATS IS WITHIN 95% CONFIDENCE INTERVAL (CI) FOR CADAVERIC SPECIMENS DOCUMENTED IN THE PACKAGE INSERT (95% CI: 93.51 ¿ 100%). FURTHER, AGGREGATED PERFORMANCE OF LOT 24562BE00 ACROSS ALL CUSTOMER SITES USING THIS LOT IS WITHIN PRODUCT REQUIREMENTS AND COMPARABLE TO THE PERFORMANCE OF OTHER LOTS OF THE SAME ASSAY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, THE ALINITY S HIV AG/AB COMBO REAGENT LOG 24562BE00 MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED.SUPPLEMENTAL 3002809144-2021-00714-02 AND 3002809144-2021-00714-03 WERE INADVERTENTLY SUBMITTED WITH INCORRECT INFORMATION IN SECTION H10. THIS SUPPLEMENTAL REPORT CONTAINS CORRECTED INFORMATION IN SECTION H10, SECTION B1 ADVERSE EVENT/PRODUCT PROBLEM, SECTION B2 OUTCOMES ATTRIBUTED TO AE, AND SECTION H1 TYPE OF REPORTABLE EVENT. THIS INFORMATION IS BEING CORRECTED FROM THE INFORMATION PROVIDED IN SUPPLEMENTAL REPORT 3002809144-2021-00714-01.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION 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 CUSTOMER DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET AND TRENDING REVIEW DETERMINED NO TRENDS FOR THE LIKELY CAUSE LOT OR COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. A CUSTOMER DATA REVIEW FOR ALINITY S HIV AG/AB COMBO, LN 6P01-60, LOT 24562BE00 WAS PERFORMED. THE ANALYSIS INCLUDED INITIAL REACTIVE RATES (IRR), REPEAT REACTIVE RATES (RRR) AND SPECIFICITY (ASSUMING ZERO PREVALENCE) AT MID AMERICA TRANSPLANT SVC (MATS), CADAVERIC PEER SITES AND ACROSS ALL CUSTOMER SITES USING THIS LOT. THE SPECIFICITY AND REACTIVE RATE PERFORMANCE OF LOT 24562BE00 AT MATS IS WITHIN 95% CONFIDENCE INTERVAL (CI) FOR CADAVERIC SPECIMENS DOCUMENTED IN THE PACKAGE INSERT (95% CI: 93.51 ¿ 100%). FURTHER, AGGREGATED PERFORMANCE OF LOT 24562BE00 ACROSS ALL CUSTOMER SITES USING THIS LOT IS WITHIN PRODUCT REQUIREMENTS AND COMPARABLE TO THE PERFORMANCE OF OTHER LOTS OF THE SAME ASSAY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY S HIV AG/AB COMBO REAGENT LOG 24562BE00 WAS IDENTIFIED. CORRECTED INFORMATION IN G1: CONTACT OFFICE FIRST NAME, CONTACT OFFICE LAST NAME, CONTACT OFFICE ADDRESS 1, CONTACT OFFICE ADDRESS 2, CONTACT OFFICE CITY, CONTACT OFFICE COUNTRY, CONTACT OFFICE POSTAL CODE, CONTACT OFFICE PHONE NUMBER, CONTACT OFFICE FAX NUMBER, CONTACT OFFICE E-MAIL

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET AND TRENDING REVIEW DID NOT IDENTIFY ANY ISSUES OR TRENDS FOR THE COMPLAINT LOTS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT. HISTORICAL PERFORMANCE WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN DATA (DIVIDED INTO 3 GROUPS) AND CAL F RLU MEAN WERE ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT AND FOUND TO BE WITHIN THE ESTABLISHED LIMITS. THEREFORE, NO UNUSUAL LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT TROPONIN-I REAGENT LOT 75304UN21 WAS IDENTIFIED.CORRECTED INFORMATION IN SECTION B1 ADVERSE EVENT/PRODUCT PROBLEM, SECTION B2 OUTCOMES ATTRIBUTED TO AE, AND SECTION H1 TYPE OF REPORTABLE EVENT. THE INFORMATION IN THE SUPPLEMENTAL REPORT WAS INCORRECTLY SELECTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET AND TRENDING REVIEW DID NOT IDENTIFY ANY ISSUES OR TRENDS FOR THE COMPLAINT LOTS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT. HISTORICAL PERFORMANCE WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN DATA (DIVIDED INTO 3 GROUPS) AND CAL F RLU MEAN WERE ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT AND FOUND TO BE WITHIN THE ESTABLISHED LIMITS. THEREFORE, NO UNUSUAL LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT TROPONIN-I REAGENT LOT 75304UN21 WAS IDENTIFIED.CORRECTED INFORMATION IN SECTION H10

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED (B)(6) ALINITY S HIV AG/AB COMBO RESULTS GENERATED ON AN ALINITY S SYSTEM FOR TWO SAMPLES. THE SAMPLES WERE FROM EYE, CORNEA, AND RETINA DONORS. THE SAMPLES GENERATED (B)(6) RESULTS VIA HIV-1 WESTERN BLOT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL RESULT= (B)(6). SAMPLE REPEATED THE NEXT DAY GENERATING RESULTS (B)6). (B)(6) HIV-1 WESTERN BLOT. THE REPEAT (B)(6) RESULTS ELIMINATED THE TISSUE/ORGANS FOR TRANSPLANT USE. NO IMPACT TO RECIPIENTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958215 ALINITY S HIV AG/AB COMBO REAGENT KIT HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES QHM ABBOTT GMBH 24562BE00 00380740117184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01,(B)(6).