BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HIV AG/AB COMBO REAGENT KIT

    MDR report key: 14170000 · Received April 21, 2022

    Report

    Report Number
    3002809144-2022-00133
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 31, 2022
    Report Date
    August 4, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117184
    PMA / PMN Number
    BL 125679
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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, REVIEW OF FIELD DATA, RETURNED SAMPLE ANALYSIS, AND A CROSS FUNCTIONAL TEAM (CFT) REVIEW. 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 COMPLAINT LIST NUMBER/LOT NUMBER OR COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. TO ASSESS THE LEVEL OF HEMOLYSIS, A VISUAL INSPECTION OF THE RETURNED CADAVERIC SAMPLE WAS PERFORMED. THE ASSESSMENT WAS PERFORMED BY APPLYING THE VISUAL INSPECTION REFERENCE GUIDE OF THE AMERICAN RED CROSS BIOMEDICAL SERVICES. PER AMERICAN AND EUROPEAN RED CROSS STANDARDS, THE ACCEPTABLE LEVEL OF HEMOLYSIS (BASED ON VISUAL/QUALITATIVE INSPECTION) IS LESS THAN 0.8%. THE FINDINGS OF THE VISUAL INSPECTION OF THE RETURNED SAMPLE SID 162162: 0.2% OF HEMOLYSIS. THE RETURNED SAMPLE WAS TESTED IN-HOUSE TO INVESTIGATE THE IMPACT OF CENTRIFUGATION SPEED/DURATION ON THE REMOVAL ON NON-SPECIFIC MATERIAL WHICH CAN BE PRESENT IN CADAVERIC SPECIMENS POTENTIALLY LEADING TO REACTIVITY OF THE SPECIMEN. SID 162162: AT 33,260 G- MINUTE CENTRIFUGATION: 0.08 S/CO, AT 75,000 G-MINUTES CENTRIFUGATION: 0.09 S/CO. THE REACTIVE RESULTS COULD NOT BE REPLICATED USING THE CUSTOMER CENTRIFUGATION CONDITION OF 33,264 G-MINUTES. INCREASING THE CENTRIFUGATION SPEED TO THE MAXIMUM DID NOT MEANINGFULLY IMPACT THE S/CO RESULTS NOR THE INTERPRETATION OF THIS SAMPLE. A TECHNICAL REVIEW OF FIELD DATA FOR ALINITY S HIV AG/AB COMBO WAS PERFORMED. OVERALL REACTIVE RATES OF LN 6P01-60, LOT 32578BE00 ACROSS CORE, APPLICABLE PEER SITES AND ACROSS ALL US CUSTOMER SITES WERE COLLECTED AND ASSESSED. ACROSS ALL US CUSTOMERS THE INITIAL REACTIVE RATE (IRR), REPEAT REACTIVE RATE (RRR) AND SPECIFICITY (ASSUMING ZERO PREVALENCE) OBSERVED FOR LOT 32578BE00 ARE WITHIN PRODUCT REQUIREMENTS, WITHIN PACKAGE INSERT SPECIFICITY CLAIMS FOR CADAVERIC SPECIMENS AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON. BOTH AT THE PEER SITES AND AT CORE THE PERFORMANCE OF LOTS 32578BE00 IS WITHIN PACKAGE INSERT SPECIFICITY CLAIMS FOR CADAVERIC SPECIMENS. THE LOT PERFORMED BETTER COMPARED TO OTHER REAGENT LOTS USED AT THE SITE. THE CFT REVIEWED AND DETERMINED THE ADVERSE EVENT WAS RELATED TO CORRECT USE AND CONCLUDED THE RISK MANAGEMENT FILE (RMF) IS ADEQUATE AND SUFFICIENTLY ADDRESSES THE ISSUE UNDER REVIEW. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, THE ALINITY S HIV AG/AB COMBO REAGENT, LOT 32578BE00, MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE AS ALL REACTIVE RATES WERE WITHIN PRODUCT REQUIREMENTS RESPECTIVELY PACKAGE INSERT CLAIMS FOR CADAVERIC TESTING. FURTHER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN SECTION D9 DEVICE AVAILABLE FOR EVAL AND DATE RETURNED TO MFG.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED (B)(6) ALINITY S HIV AG/AB COMBO RESULTS GENERATED ON AN ALINITY S SYSTEM FROM A CADAVERIC TISSUE DONOR. (B)(6) INITIAL RESULT = (B)(6), REPEAT RESULTS = (B)(6). THE SAMPLE WAS (B)(6) ON ELISA AND NAT. THE DONATED TISSUE WAS DISCARDED DUE TO THE (B)(6) HIV RESULTS. NO OTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327983 ALINITY S HIV AG/AB COMBO REAGENT KIT HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES QHM ABBOTT GMBH 32578BE00 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)