BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HBSAG REAGENT KIT

    MDR report key: 14279002 · Received May 4, 2022

    Report

    Report Number
    3008344661-2022-00039
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 23, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QHM
    UDI-DI
    00380740136819
    PMA / PMN Number
    BL 125674
    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

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT NUMBER 35562FN00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. TICKET SEARCHES DETERMINED THAT THERE IS A NORMAL COMPLAINT ACTIVITY FOR THE PRODUCT AND LOT. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. PER COMPLAINT TICKET DOCUMENTATION, AT LEAST ONE OF THE AFFECTED SAMPLES IS DESCRIBED AS HEMOLYZED. TO ASSESS THE LEVEL OF HEMOLYSIS, A VISUAL INSPECTION OF THE RETURNED CADAVERIC SAMPLES 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 FOLLOWING TABLE SUMMARIZES THE FINDINGS OF THE VISUAL INSPECTION OF THE RETURNED SAMPLES: 163505: 0.2% OF HEMOLYSIS 163457: 1.7% OF HEMOLYSIS 163619: 1.0% OF HEMOLYSIS 164007: 0.2% OF HEMOLYSIS CENTER FOR ORGAN RECOVERY AND EDUCATION (CORE) RETURNED A TOTAL OF FOUR SAMPLES (SAMPLES 163457, 163505, 163619, AND 164007). THE RETURNED SAMPLES WERE TESTED IN-HOUSE TO INVESTIGATE THE IMPACT OF CENTRIFUGATION SPEED/DURATION ON THE REMOVAL OF NON-SPECIFIC MATERIAL WHICH CAN BE PRESENT IN CADAVERIC SPECIMEN POTENTIALLY LEADING TO REACTIVITY OF THE SPECIMENS. ADDITIONALLY, SPECIMENS WERE TO BE EVALUATED USING ALINITY S HBSAG CONFIRMATORY ASSAY TO FURTHER CHARACTERIZE THE PRESENCE OF ANALYTE WHICH LED TO THE REACTIVE RESULTS. HBSAG RESULTS: SID 163457: AT 59,140 G-MINUTES CENTRIFUGATION: 1.08 S/CO AT 75,000 G-MINUTES CENTRIFUGATION: 0.80 S/CO HBSAG CONFIRMATORY: NOT CONFIRMED SID 163505: AT 59,140 G-MINUTES CENTRIFUGATION: 1.51 S/CO AT 75,000 G-MINUTES CENTRIFUGATION: 1.49 S/CO HBSAG CONFIRMATORY: NOT CONFIRMED SID 163619: AT 59,140 G-MINUTES CENTRIFUGATION: 1.56 S/CO AT 75,000 G-MINUTES CENTRIFUGATION: NOT SUFFICIENT VOLUME HBSAG CONFIRMATORY: NOT CONFIRMED SID 164007: AT 59,140 G-MINUTES CENTRIFUGATION: 2.07 S/CO AT 75,000 G-MINUTES CENTRIFUGATION: 1.51 S/CO HBSAG CONFIRMATORY: NOT CONFIRMED THE REACTIVE RESULTS OBSERVED AT CORE FOR RETURNED SAMPLES ASSOCIATED WITH ALINITY S HBSAG COMPLAINT 056056FC1083477 WERE REPLICATED AT ABBOTT UNDER EXPERIMENTAL CONDITIONS. ONE SAMPLE, INITIALLY TESTING NEAR THE CUT-OFF (1.08 S/CO) AT THE CUSTOMER CENTRIFUGATION CONDITION ALTERED DISPOSITION TO ¿NON-REACTIVE¿ AFTER CENTRIFUGATION AT THE MAXIMUM RECOMMENDED CENTRIFUGATION CONDITION OF 75,000 G-MINUTES. HOWEVER, AFTER NEUTRALIZATION TESTING USING ALINITY S HBSAG CONFIRMATORY TESTING, ALL SAMPLES ASSOCIATED WITH ALINITY S HBSAG COMPLAINT 056056FC1083477 HAD A FINAL DISPOSITION OF ¿NOT CONFIRMED¿. IN SUMMARY, MODULATION OF THE CENTRIFUGATION CONDITION (I.E. 59,136 G-MIN, OR 75,000 G-MIN) INCONSISTENTLY IMPACTED THE RESULT INTERPRETATIONS FOR THOSE SAMPLES TESTED USING BOTH CENTRIFUGATION CONDITIONS. A TECHNICAL REVIEW OF FIELD DATA FOR ALINITY S HBSAG WAS PERFORMED. OVERALL REACTIVE RATES OF LN 6P02-60, LOT 35562FN00 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 35562FN00 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 LOT 35562FN00 IS WITHIN PACKAGE INSERT SPECIFICITY CLAIMS FOR CADAVERIC SPECIMENS. BOTH LOTS PERFORMED BETTER COMPARED TO THE OTHER HBSAG REAGENT LOT USED AT THE SITE. PERFORMANCE ACROSS ALL US SITES: LOT 35562FN00: IRR: 0.038 %, IRR (WITHOUT REPEAT REACTIVES): 0.025 %, RRR: 0.013 % SPECIFICITY: 99.987% PERFORMANCE ACROSS ALL PEER SITES (EXCLUDING CORE): LOT 35562FN00: IRR: 5.479 %, RRR: 5.479 % SPECIFICITY: 94.521% PERFORMANCE ACROSS CORE: LOT 35562FN00: IRR: 1.993 %, RRR: 1.661 % SPECIFICITY: 98.339% A CROSS FUNCTIONAL TEAM (CFT) CONSISTING OF MEDICAL AFFAIRS, QUALITY AND TECHNICAL OPERATIONS 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. BASED ON THE RESULTS OF THIS INVESTIGATION, ALINITY S HBSAG, LN 6P02-60, LOT 35562FN00, IS PERFORMING AS EXPECTED. NO MALFUNCTION WAS IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS 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. CORRECTION TO SECTION B5. AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THE NONREACTIVE RESULT OF 0.23 S/CO WAS NOT ASSOCIATED WITH SID 163505 AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG RESULTS FOR ONE RESEARCH DONOR SAMPLE. THE SAMPLE WAS SLIGHTLY HEMOLYZED HOWEVER FREE OF PARTICULATE MATTER. THE SAMPLE WAS REPEATEDLY REACTIVE. SID (B)(6) (RESEARCH USE ONLY DONOR) RESULTS WERE 0.23 S/CO, REPEATED 1.65 / 2.12 / 2.23 S/CO THE RESEARCH USE ONLY DONOR WAS DISCARDED (B)(6). THE CUSTOMER DID NOT PERFORM NAT TESTING OR THE NEUTRALIZATION ASSAY ON THE RESEARCH DONOR (163505) AS PER CUSTOMER POLICY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE RESEARCH USE ONLY DONOR WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552420 ALINITY S HBSAG REAGENT KIT ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM) QHM ABBOTT IRELAND 35562FN00 00380740136819

    Patients

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