BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL ACUSTAR HIT-IGG(PF4-H)

    MDR report key: 22161249 · Received June 6, 2025

    Report

    Report Number
    1217183-2025-00033
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 21, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LCO
    UDI-DI
    08426951126545
    PMA / PMN Number
    K170854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NOTE: HEMOSIL ACUSTAR HIT-IGG (PF4-H) IS SOLD OUTSIDE OF THE U.S. UNDER PART NUMBER 0009802028. THIS SAME ASSAY IS FDA CLEARED UNDER K170854 AND SOLD IN THE U.S. UNDER PART NUMBER 0009800127. DUE TO THE SIMILARITY, THE INCIDENT, WHICH OCCURRED OUTSIDE THE U.S. UNDER PART NUMBER 0009802028, IS CONSIDERED REPORTABLE.

    Additional Manufacturer Narrative · 0

    QC AND MANUFACTURING DATA FOR HEMOSIL ACUSTAR HIT-IGG(PF4-H) WERE REVIEWED AND NO ISSUES OR TRENDS WERE IDENTIFIED WITH THE IMPACTED LOT. BASED ON INFORMATION AVAILABLE, 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. THE LOG FILES FOR THE DATE RANGE WHEN THE SAMPLE WAS RUN ARE UNAVAILABLE FROM THE CUSTOMER, SO A FULL ANALYSIS COULD NOT BE COMPLETED. HEMOSIL ACUSTAR HIT-IGG (PF4-H) LOT B36603 WAS EXPIRED. TO VERIFY PERFORMANCE, AN IN HOUSE EVALUATION WAS PERFORMED USING ADDITIONAL LOTS. NO ERRORS FOUND RELATED TO QC RUNS DURING THE TIME PERIOD OF THE REFERENCED DISCREPANCIES ISSUES. 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, (B)(4), 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. A PF4/HEPARIN (PF4/H) ANTIBODY ASSAY, SUCH AS HEMOSIL ACUSTAR HIT-IGG(PF4-H), IS INTENDED TO BE USED IN CONJUNCTION WITH A COMPREHENSIVE CLINICAL EVALUATION AND NOT AS A STAND-ALONE DIAGNOSTIC TOOL. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CUSTOMER REPORTED 3 PATIENTS WITH DISCREPANT RESULTS BETWEEN HEMOSIL ACUSTAR HIT IGG (PF4-H) (NEGATIVE RESULTS) AND ELISA METHOD (POSITIVE RESULTS). NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719863 HEMOSIL ACUSTAR HIT-IGG(PF4-H) PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO INSTRUMENTATION LABORATORY CO. 08426951126545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown