BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL HIT-AB(PF4-H)

    MDR report key: 21599401 · Received March 13, 2025

    Report

    Report Number
    1217183-2025-00015
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    January 9, 2024
    Report Date
    March 13, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LCO
    UDI-DI
    08426950584971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: HEMOSIL HIT-IGG(PF4-H) IS SOLD OUTSIDE OF THE U.S. UNDER PART NUMBER 0020302700 LABELED AS A SEMI-QUANTITATIVE ASSAY. THIS SAME ASSAY IS FDA CLEARED UNDER K153137 AND SOLD IN THE U.S. UNDER PART NUMBER 0020014600 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 0020302700, IS CONSIDERED REPORTABLE. AT THE TIME OF THE REPORTED COMPLAINT, INSTRUMENTATION LABORATORY CO. CONDUCTED A COMPREHENSIVE INVESTIGATION, INCLUDING A REVIEW OF THE INSTRUMENT BACKUP. THE REVIEW CONFIRMED THAT QUALITY CONTROL WAS WITHIN SPECIFICATIONS. THE INSTRUMENT BACKUP INCLUDED THE SAMPLE RESULTS (0.7 U/ML AND 0.8 U/ML) REPORTED BY THE CUSTOMER; HOWEVER, THE ROOT CAUSE OF THESE NEGATIVE RESULTS COULD NOT BE CONCLUSIVELY DETERMINED. PER THE LABELING FOR HEMOSIL HIT-IGG(PF4-H), ASSAY RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS AND NOT USED IN ISOLATION TO EXCLUDE HIT. AS A RESULT, THE COMPLAINT WAS CLOSED, AND NO REMEDIAL ACTION WAS DEEMED NECESSARY. IMPORTANT NOTE: INSTRUMENTATION LABORATORY CO. RECENTLY CONDUCTED A SELF-ASSESSMENT OF ITS QUALITY MANAGEMENT SYSTEM AS PART OF ITS ONGOING COMPLIANCE AND QUALITY PROGRAM DUE DILIGENCE. ONE ASPECT OF THIS ASSESSMENT WAS TO PERFORM A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS RECEIVED OVER THE PAST TWO YEARS, TO ASSESS IF ANY COMPLAINTS SHOULD HAVE BEEN REPORTED TO FDA FOLLOWING THE FDA GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS". AS PART OF THIS ASSESSMENT, WE IDENTIFIED A SMALL NUMBER OF COMPLAINTS THAT REQUIRE RETROSPECTIVE REPORTING. PLEASE BE ASSURED THAT INSTRUMENTATION LABORATORY TAKES ITS REGULATORY RESPONSIBILITIES TO THE FDA AND ITS CUSTOMERS SERIOUSLY AND STRIVES TO PRODUCE ONLY THE HIGHEST QUALITY DEVICES. THE NUMBER OF LATE REPORTED COMPLAINTS IS LESS THAN 0.005% OF THE ANNUAL COMPLAINT VOLUME RECEIVED AND A CAPA HAS BEEN INITIATED TO MITIGATE FUTURE OCCURRENCES. FURTHERMORE, THE COMPANY HAS AND WILL CONTINUE TO DEDICATE THE NECESSARY FINANCIAL AND PERSONNEL RESOURCES (AND MANAGEMENT OVERSIGHT) TO COMPLETE THESE ACTION PLANS IN A TIMELY MANNER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT A PATIENT TESTED NEGATIVE (0.7 U/ML) USING HEMOSIL HIT-IGG (PF4-H), AND A RERUN WAS ALSO NEGATIVE (0.8 U/ML). THE CLINICIAN DID NOT AGREE WITH THE RESULTS, SO THE SAMPLE WAS SENT TO A DIFFERENT SITE AND TESTED WITH HEMOSIL ACUSTAR HIT-IGG(PF4-H), AND THE RESULT WAS POSITIVE (2.34 U/ML). NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689666 HEMOSIL HIT-AB(PF4-H) PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO INSTRUMENTATION LABORATORY CO. B35902 08426950584971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown