BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HBSAG REAGENT KIT

    MDR report key: 15668070 · Received October 25, 2022

    Report

    Report Number
    3008344661-2022-00135
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    September 15, 2022
    Report Date
    January 10, 2023
    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
    VA, 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. NOTE: EMDR-40487: MFR 3008344661-2022-00127-00 IS FOR SID (B)(6). EMDR-40530: MFR 3008344661-2022-00128-00 IS FOR SID (B)(6). EMDR-40531: MFR 3008344661-2022-00129-00 IS FOR SID (B)(6). EMDR-40532: MFR 3008344661-2022-00130-00 IS FOR SID (B)(6). EMDR-40533: MFR 3008344661-2022-00131-00 IS FOR SID (B)(6). EMDR-40534: MFR 3008344661-2022-00132-00 IS FOR SID (B)(6). EMDR-40535: MFR 3008344661-2022-00133-00 IS FOR SID (B)(6). EMDR-40536: MFR 3008344661-2022-00134-00 IS FOR SID (B)(6). EMDR-40537: MFR 3008344661-2022-00135-00 IS FOR SID (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY S HBSAG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. ADDITIONALLY, RETURN SAMPLE TESTING WAS COMPLETED. LIFENET HEALTH RETURNED A TOTAL OF NINE CADAVERIC SAMPLES TO ABBOTT FOR THE INVESTIGATION. PER THE COMPLAINT DOCUMENTATION, THE SAMPLES WERE DESCRIBED AS RANGING FROM SLIGHTLY TO GROSSLY 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. ADDITIONALLY, CELL-DYN SAPPHIRE HEMOGLOBIN AND ALINITY S HBSAG TESTING WAS PERFORMED. (* PER THE COMPLAINT DOCUMENTATION THE FIRST 3 SIDS RECEIVED WERE PULLED FROM ARCHIVE AND THAT IS WHY THE IDS RECEIVED ARE DIFFERENT. CUSTOMER NO LONGER HAD THE 3 SAMPLES FROM THE ALINITY S RUN AND PROVIDED THE ARCHIVE SAMPLE. THE ARCHIVE SAMPLES ARE THE SAME SERUM AND COLLECTION DATE/TIME AS THE SAMPLES RUN ON THE ALINITY S.) SID (B)(6)((B)(6)*) = 1.7% OF HEMOLYSIS, 541 HEMOGLOBIN , HBSAG = 1.07 S/CO, SID (B)(6)((B)(6)*) = 0.9% OF HEMOLYSIS, 434 HEMOGLOBIN , HBSAG = 3.40 S/CO, SID (B)(6)((B)(6)*) = 2% OF HEMOLYSIS, 1755 HEMOGLOBIN , HBSAG = 0.68 S/CO, SID (B)(6)= 0.9% OF HEMOLYSIS, 113 HEMOGLOBIN , HBSAG = 2.27 S/CO, SID (B)(6)= 2% OF HEMOLYSIS, 822 HEMOGLOBIN , HBSAG = 2.09 S/CO, SID (B)(6)= 1% OF HEMOLYSIS, 269 HEMOGLOBIN , HBSAG = 1.55 S/CO, SID (B)(6)= 0.9% OF HEMOLYSIS, 224 HEMOGLOBIN , HBSAG = 1.24 S/CO, SID (B)(6)= 2% OF HEMOLYSIS, 2443 HEMOGLOBIN , HBSAG = 3.54 S/CO, SID (B)(6)= 2% OF HEMOLYSIS, 329 HEMOGLOBIN , HBSAG = 1.10 S/CO. PER THE AMERICAN AND EUROPEAN RED CROSS STANDARDS, THE ACCEPTABLE LEVEL OF HEMOLYSIS (BASED ON VISUAL/QUALITATIVE INSPECTION) IS LESS THAN 0.8%. ALL 9 SAMPLES EXCEED THE ACCEPTABLE LEVEL OF HEMOLYSIS PER THE AMERICAN AND EUROPEAN RED CROSS STANDARDS. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 35562FN00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. A TECHNICAL REVIEW OF FIELD DATA FOR ALINITY S HBSAG WAS PERFORMED. OVERALL REACTIVE RATES OF LOT 35562FN00 ACROSS LIFENET HEALTH, 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 REPRESENTATIVE DATA AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON. AT LIFENET HEALTH THE PERFORMANCE OF LOT 35562FN00 IS WITHIN PACKAGE INSERT REPRESENTATIVE DATA, HOWEVER THE IR-RR RATES ARE HIGHER AS COMPARED TO PEER SITES. 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. BASED ON THE INVESTIGATION ALINITY S HBSAG REAGENT LOT 35562FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY S HBSAG REAGENT WAS IDENTIFIED. NOTE: EMDR-40487: MFR 3008344661-2022-00127-01 IS FOR SID (B)(6), EMDR-40530: MFR 3008344661-2022-00128-01 IS FOR SID (B)(6), EMDR-40531: MFR 3008344661-2022-00129-01 IS FOR SID (B)(6), EMDR-40532: MFR 3008344661-2022-00130-01 IS FOR SID (B)(6), EMDR-40533: MFR 3008344661-2022-00131-01 IS FOR SID (B)(6), EMDR-40534: MFR 3008344661-2022-00132-01 IS FOR SID (B)(6), EMDR-40535: MFR 3008344661-2022-00133-01 IS FOR SID (B)(6), EMDR-40536: MFR 3008344661-2022-00134-01 IS FOR SID (B)(6), EMDR-40537: MFR 3008344661-2022-00135-01 IS FOR SID (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG RESULTS FOR MULTIPLE CADAVERIC TISSUE DONOR SERUM SAMPLES THAT WERE NAT NEGATIVE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE IS S/CO): (B)(6) 2022, SID (B)(6), INITIAL RESULT = 1.15, REPEATS = 1.2 AND 1.19, HEMOLYSIS WAS 1+. (B)(6) 2022, SID (B)(6), INITIAL RESULT = 3.5, REPEATS = 3.43 AND 3.5, HEMOLYSIS WAS 1+. (B)(6) 2022, SID (B)(6), INITIAL RESULT = 3.32, REPEATS = 2.56 AND 2.91, HEMOLYSIS WAS 4+. (B)(6) 2022, SID (B)(6), INITIAL RESULT = 5.01, REPEATS = 4.68 AND 4.94, HEMOLYSIS WAS 1+. (B)(6) 2022, SID (B)(6), INITIAL RESULT = 3.82, REPEATS = 3.85 AND 3.77, HEMOLYSIS WAS 4+. (B)(6) 2022, SID (B)(6), INITIAL RESULT = 3.81, REPEATS = 3.52 AND 3.48, HEMOLYSIS WAS 1+. (B)(6) 2022, SID (B)(6), INITIAL RESULT = 2.18, REPEATS = 1.91 AND 1.97, HEMOLYSIS WAS 1+. TWO ADDITIONAL SAMPLES (SID (B)(6) WITH GROSS HEMOLYSIS AND (B)(6) WITH SLIGHT HEMOLYSIS) WERE ALSO REPEAT REACTIVE AND NAT NEGATIVE. THE TISSUE WAS DISCARDED FOR ALL IMPACTED SIDS (B)(6). NEUTRALIZING CONFIRMATORY TESTING WAS NOT COMPLETED AS CADAVERIC SAMPLE TESTING IS NOT ALLOWED PER THE CORRESPONDING HBSAG CONFIRMATORY ASSAY PACKAGE INSERT. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480375 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, AS1370| ALNTY S SYSTEM, 06P16-01, AS1370