BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL ACUSTAR HIT-IGG (PF4-H)

    MDR report key: 21801436 · Received April 8, 2025

    Report

    Report Number
    1217183-2025-00027
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    September 4, 2024
    Report Date
    July 23, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LCO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. NOTE: HEMOSIL ACUSTAR HIT-IGG(PF4-H) IS SOLD OUTSIDE OF THE U.S. UNDER PART NUMBER 0009802028 LABELED AS A SEMIQUANTITATIVE ASSAY. THIS SAME ASSAY IS FDA CLEARED UNDER K170854 AND SOLD IN THE U.S. UNDER PART NUMBER 0009800127 LABELED AS A QUALITATIVE ASSAY. BOTH THE U.S. AND INTERNATIONAL VERSIONS SHARE THE SAME FORMULATION AND MEDICAL CUT-OFF. DUE TO THE SIMILARITY, THE INCIDENT, WHICH OCCURRED OUTSIDE THE U.S. UNDER PART NUMBER 0009802028, IS CONSIDERED REPORTABLE.

    Additional Manufacturer Narrative · 0

    PRINTOUTS AND THE INSTRUMENT BACKUP WERE PROVIDED FOR REVIEW. QC AND MANUFACTURING DATA FOR HEMOSIL ACUSTAR HIT-IGG(PF4-H) LOT B36603 WERE REVIEWED, AND NO ISSUES OR TRENDS WERE IDENTIFIED WITH THE IMPACTED LOT. THE PRINTOUTS SHOWED TWO RESULTS OBTAINED WITH THE ELISA METHOD 1.025 (MEAN OF 2 RESULTS: 2.061 AND 0.089) WAS CONSIDERED HIT POSITIVE, PER CUSTOMER. DATA REVIEW IDENTIFIED THE SAMPLE IN QUESTION (9/4/24 A HIT RESULT OF 0.47 U/M). THE REAGENT LOT B36603 USED DURING SAMPLE ANALYSIS WAS CALIBRATED ON 8/27/24, BUT THE DETAILS OF THE CALIBRATION COULD NOT BE CHECKED IN THE BACKUP. CALIBRATION FROM OTHER HEMOSIL ACUSTAR HIT IGG (PF4-H) REAGENT LOTS (B36962 AND B37008) WERE ONLY OBSERVED. REAGENT ASPIRATION WAS CHECKED FOR THE AFFECTED CARTRIDGE SN 664, AND NO ISSUES WERE OBSERVED. THE SAMPLE ID (B)(6) PROVIDED BY THE CUSTOMER FOR COMPLAINT INVESTIGATION WAS NOT FOUND IN THE BACKUP REVIEW SO A FULL ANALYSIS COULD NOT BE DONE. THE SYSTEM BACKUP WAS REVIEWED FOR THE INSTRUMENT PERFORMANCE FROM 8/1/24 TO 3/31/25. THERE WERE NO ISSUES FOUND WITH THE HARDWARE; STABLE PERFORMANCE WAS OBSERVED. REAGENT USAGE WAS ALSO REVIEWED, AND NO ASPIRATION ISSUES FOR REAGENTS WERE NOTED, PERFORMANCE WAS STABLE. NO ERRORS WERE FOUND RELATING TO THE QC RUNS DURING THE TIME PERIOD. THE LOGS THAT TRACK SAMPLE PERFORMANCE AND ASPIRATION WERE NOT AVAILABLE FOR ANALYSIS. THEREFORE, A FULL ASSESSMENT OF THE SAMPLE PERFORMANCE COULD NOT BE COMPLETED. TO VERIFY THE PERFORMANCE OF HEMOSIL ACUSTAR HIT-IGG (PF4-H) LOT B36603, AN IN-HOUSE EVALUATION CONFIRMED NEGATIVE RESULT WITH THIS METHOD AS WELL AS WITH THE ELISA IMMUCOR LOT 3014184. WHEREAS THE SAMPLE REPORTED POSITIVE RESULTS (AND ABOVE THE LINEARITY RANGE) WHEN IT WAS TESTED WITH THE HEMOSIL HIT-AB(PF4-H) LOT B36908. HEMOSIL ACUSTAR HIT-IGG(PF4-H) IS A FULLY AUTOMATED CHEMILUMINESCENT IMMUNOASSAY FOR THE DETECTION OF IGG ANTIBODIES IN HUMAN CITRATED PLASMA AND SERUM THAT REACT WITH PLATELET FACTOR 4 (PF4) WHEN COMPLEXED TO HEPARIN ON THE ACL ACUSTAR. HEPARIN-ASSOCIATED ANTIBODIES ARE COMMONLY FOUND IN PATIENTS WITH HEPARIN INDUCED THROMBOCYTOPENIA OR THROMBOSIS (HIT). A CLINICAL REASSESSMENT SUPPORTED BY LABORATORY DATA SHOULD BE PERFORMED BEFORE CONFIRMATION OR EXCLUSION OF THE DIAGNOSIS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OF HEMOSIL ACUSTAR HIT-IGG(PF4-H), AS PER PRODUCT DESIGN A % OF SAMPLES MAY SHOW DISCREPANT RESULTS WITH OTHER METHODS. FOR HEMOSIL ACUSTAR HIT-IGG(PF4-H) VS. TWO ELISA ASSAYS, THE TOTAL % AGREEMENT (95% CI) IS BETWEEN 89.7% AND 95.0% AND BETWEEN 91.7 % AND 97.9% DEPENDING IF THE ASSAY IS PERFORMED ON PLASMA OR SERUM SAMPLES. THESE FIGURES SUGGEST THAT DISCREPANCIES MAY ARISE IN SPECIFIC SAMPLES WHEN COMPARING HEMOSIL ACUSTAR HIT-IGG (PF4-H) WITH OTHER METHODOLOGIES. ALTHOUGH THE RESULTS WERE CONFIRMED, THERE WAS NO MALFUNCTION IDENTIFIED DURING INVESTIGATION. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DISCREPANT RESULTS WHEN USING THE REAGENT HEMOSIL ACUSTAR HIT-IGG(PF4-H) COMPARED WITH RESULTS OBTAINED ON THE LABORATORY'S ACL ACUSTAR SN (B)(6) AND OTHER METHODS (STAGO, ELISA, AND SRA). ON SEPTEMBER 4, 2024, THE CUSTOMER RECEIVED A FROZEN ALIQUOT FROM ANOTHER LABORATORY TESTED ON STIC EXPERT REAGENT (STAGO) WITH A POSITIVE RESULT. THE RESULT OBTAINED USING HEMOSIL ACUSTAR HIT-IGG(PF4-H) ON ACL ACUSTAR SYSTEM WAS 0.47 U/ML, A NEGATIVE RESULT. THE SAME ALIQUOT WAS TESTED WITH ELISA METHOD WITH A POSITIVE RESULT. THE SAMPLE WAS SENT TO A REFERENCE CENTER AND TESTED USING RADIOLABELED SEROTONIN RELEASE TEST WITH A POSITIVE RESULT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT WITH REGARD TO THE SCORE RESULTS.

    Description of Event or Problem · 0

    A COMPLAINT WAS SUBMITTED INDICATING THAT THERE WERE DISCREPANT RESULTS FOR A PATIENT SAMPLE USING ON HEMOSIL ACUSTAR HIT-IGG(PF4-H) LOT B36603 ON ACL ACUSTAR SN (B)(6), REPORTING 0.47 U/ML (NEGATIVE). THE PATIENT SAMPLE WAS RECEIVED FROM ANOTHER LABORATORY. THE RESULT FROM THE OTHER LABORATORY WAS POSITIVE ON STIC EXPERT HIT (STAGO). THE SAMPLE WAS TESTED WITH ELISA AND WAS POSITIVE. FURTHERMORE, THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH RADIOLABELED SEROTONIN RELEASE TEST (SRA) AND THE RESULT WAS POSITIVE TOO. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223948 HEMOSIL ACUSTAR HIT-IGG (PF4-H) PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO INSTRUMENTATION LABORATORY CO. B36603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown