BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HBSAG REAGENT KIT

    MDR report key: 15536382 · Received October 4, 2022

    Report

    Report Number
    3008344661-2022-00120
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    October 1, 2022
    Report Date
    December 19, 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

    ALL AVAILABLE PATIENT INFORMATION IS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINT DATA FOR THE ALINITY S HBSAG ASSAY, LIST NUMBER (LN) (B)(4), LOT 36342FN00, WAS PERFORMED AND IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE COMPLAINT ISSUE. A REVIEW OF TICKET TRENDING WAS PERFORMED AND DID NOT IDENTIFY ANY TRENDS. A REVIEW OF LABELING WAS ALSO PERFORMED AND CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. THE PERFORMANCE OF THE ALINITY S HBSAG REAGENT LOT 36342FN00 WAS INVESTIGATED BY COMPLETING A REVIEW IN THE CAPA SYSTEM FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LOT; THERE WERE NO EVENTS OR ISSUES FOUND THAT MAY HAVE IMPACTED THE PERFORMANCE OF THE LOT NUMBER IN RELATION TO THE COMPLAINT ISSUE. 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 RISK MANAGEMENT FILE (RMF) IS ADEQUATE AND SUFFICIENTLY ADDRESSES THE ISSUE UNDER REVIEW. THE CENTER FOR ORGAN RECOVERY AND EDUCATION (CORE) RETURNED A TOTAL OF FIVE CADAVERIC SAMPLES ((B)(4)) TO ABBOTT FOR THE INVESTIGATION. PER THE COMPLAINT DOCUMENTATION, SOME OF THE SAMPLES WERE DESCRIBED AS SLIGHTLY HEMOLYZED. TO ASSESS THE LEVEL OF HEMOLYSIS, A VISUAL INSPECTION OF THE RETURNED CADAVERIC SAMPLES WAS PERFORMED. ALL 5 SAMPLES WERE NOTED TO EXCEED THE ACCEPTABLE LEVEL OF HEMOLYSIS PER THE AMERICAN AND EUROPEAN RED CROSS STANDARDS. ADDITIONALLY, ALINITY S HBSAG TESTING WAS PERFORMED ON THE RETURNED SPECIMENS. OF THE 5 SAMPLES, 3 WERE NONREACTIVE AND 2 WERE REACTIVE. A TECHNICAL REVIEW OF FIELD DATA FOR ALINITY S HBSAG WAS ALSO PERFORMED. THE REVIEW CONSISTED OF LOOKING AT THE OVERALL REACTIVE RATES OF (B)(4), LOT 36342FN00 ACROSS CORE, APPLICABLE PEER SITES AND ACROSS ALL US CUSTOMER SITES. IT WAS NOTED THAT ACROSS ALL US CUSTOMERS, THE INITIAL REACTIVE RATE (IRR), REPEAT REACTIVE RATE (RRR) AND SPECIFICITY (ASSUMING ZERO PREVALENCE) OBSERVED FOR LOT 36342FN00 IS WITHIN PRODUCT REQUIREMENTS, WITHIN PACKAGE INSERT REPRESENTATIVE DATA FOR CADAVERIC SPECIMENS AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON. ADDITIONALLY, AT CORE THE PERFORMANCE OF LOT 36342FN00 WAS NOTED TO BE WITHIN PACKAGE INSERT REPRESENTATIVE DATA FOR CADAVERIC SPECIMENS. LOT 3642FN00 WAS NOT TESTED AT PEER SITES AT THE TIME OF THE REVIEW. BASED ON THE RESULTS OF THE INVESTIGATION, THE ALINITY S HBSAG, LN (B)(4), LOT 36342FN00, IS PERFORMING AS EXPECTED AND THE DEVICE MET PERFORMANCE SPECIFICATIONS AT THE CUSTOMER SITE AS ALL REACTIVE RATES WERE WITHIN PRODUCT REQUIREMENTS RESPECTIVELY PACKAGE INSERT REPRESENTATIVE DATA FOR CADAVERIC TESTING. FURTHER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED FALSE REPEATEDLY REACTIVE ALINITY S HBSAG RESULTS FOR A DONOR SAMPLE WHILE RUNNING ON THE ALINITY S SYSTEM. THE DONOR SAMPLE WAS A CADAVERIC SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID 172932 (B)(6) FEMALE): ON (B)(6) 2022 INITIAL: 1.46 S/CO; ON (B)(6) 2022 REPEAT 1: 1.14 S/CO; REPEAT 2: 1.23 S/CO; ANTI- HBC: NEGATIVE; NAT: NEGATIVE (TISSUE WAS DISCARDED); SLIGHTLY HEMOLYZED. THE DONATED TISSUE WAS DISCARDED. THERE WAS NO OTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2931355 ALINITY S HBSAG REAGENT KIT ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM) QHM ABBOTT IRELAND 36342FN00 00380740136819

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Disability ALNTY S SYSTEM, 06P16-01, AS1346| ALNTY S SYSTEM, 06P16-01, AS1346