BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL HIT- AB(PF4-H)

    MDR report key: 22737450 · Received August 7, 2025

    Report

    Report Number
    1217183-2025-00040
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    April 9, 2025
    Report Date
    September 4, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LCO
    UDI-DI
    08426950975380
    PMA / PMN Number
    K153137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    THE CERTIFICATE OF ANALYSIS (COA) FOR HEMOSIL HIT-AB (PF4-H), LOT: B37012, PN: 00020014600 WAS REVIEWED. THE REAGENT MET ALL REQUIRED SPECIFICATIONS, AND NO ABNORMALITIES WERE IDENTIFIED. REVIEW OF THE SUBMITTED SAMPLE RESULT REPORT INDICATES THAT AN ON-BOARD DILUTION TEST WAS PERFORMED. THE LABORATORY USER MISTAKENLY ORDERED AND PERFORMED A HIT ALTERNATIVE PREDILUTION (D) TEST INSTEAD OF THE STANDARD HIT_AB TEST. THE HIT ALTERNATIVE PREDILUTION (D) TEST INVOLVES A 1:4 DILUTION OF THE PATIENT'S PLASMA. THIS PROCESS CAN LEAD TO OVER-DILUTION OF ANTI-PF4/HEPARIN ANTIBODIES, ESPECIALLY IN PATIENTS WHO ALREADY HAVE A LOW CONCENTRATION OF THESE ANTIBODIES. TO MINIMIZE THIS RISK, IT IS RECOMMENDED TO PERFORM THE STANDARD HIT_AB TEST FIRST AND ONLY PROCEED WITH THE DILUTED TEST AS DEFINED IN THE WERFEN-LOCKED TEST DEFINITION. PATIENT IMPACT IS UNKNOWN. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.

    Description of Event or Problem · 0

    POTENTIALLY ERRONEOUS RESULT GENERATED DUE TO HIT ALTERNATIVE PREDILUTION (D) TEST BEING ORDERED INSTEAD OF THE MAIN TEST USING HEMOSIL HIT-AB (PF4-H) LOT B37012 ON ACL TOP 550 CTS SN (B)(6). A COMPLAINT WAS SUBMITTED ON HEMOSIL HIT-AB (PF4-H), LOT B37012, PN 00020014600, INDICATING THAT A LABORATORY USER MISTAKENLY ORDERED AND PERFORMED A HIT ALTERNATIVE PREDILUTION (D) TEST INSTEAD OF THE STANDARD HIT_AB TEST ON (B)(6) 2025. AT THIS TIME, THE IMPACT ON THE PATIENT REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005871 HEMOSIL HIT- AB(PF4-H) PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO INSTRUMENTATION LABORATORY CO. B37012 08426950975380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown