BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSIL HIT- AB(PF4-H)

    MDR report key: 22100252 · Received May 28, 2025

    Report

    Report Number
    1217183-2025-00032
    Event Type
    Death
    Date Received
    May 28, 2025
    Date of Event
    May 23, 2025
    Report Date
    July 17, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LCO
    UDI-DI
    08426950975380
    PMA / PMN Number
    K153137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    QC AND MANUFACTURING DATA FOR HEMOSIL HIT-AB(PF4-H) LOT B37250 WERE REVIEWED AND NO ISSUES OR TRENDS WERE IDENTIFIED WITH THE IMPACTED LOT. REVIEW OF SUBMITTED CALIBRATION REPORT CONFIRMS THAT HIT-AB LOT B37250 WAS CALIBRATED ON 4/17/2025 APRIL 17, 2025, USING THE CORRECT TARGET VALUE OF 5.5 U/ML, AND THE RESULTS WERE PROPRELY VALIDATED. QC RESULTS WERE PERFORMED AFTER THE CALIBRATION WAS VALIDATED AND WERE CONFIRMED WITHIN ACCEPTABLE RANGE FOR HIT_AB CONTROLS LOT B37286. REVIEW OF THE SUBMITTED QC LEVEY JENNINGS CHARTS FOR 05/01/2025 TO 05/19/2025 SHOWS THE HIT ANTIBODIES FOR ACL TOP 350, HIT LOW AND HIGH LOT # B37286 REPORTED ACCEPTABLE RESULTS ON 05/08/2025 PRIOR TO SAMPLE TESTING. REVIEW OF THE SERVICE HISTORY SHOWS CALL 2005283457 ON 5/27/2025 - THE FIELD SERVICE ENGINEER VERIFIED THE INSTRUMENT FOR THE HIT DISCREPANT RESULTS. PREVENTATIVE MAINTENANCE FOR THE INSTRUMENT WAS LAST COMPLETED ON 4/25/25. NO INSTRUMENT ISSUES FOUND AT THAT TIME. REVIEWED GENERAL LOG LIST, CLEANED AND INSPECTED INSTRUMENT; NO ISSUES FOUND. FLUIDIC PRECISION PASSES BOTH ARMS. FLOW RATE PERFORMED AND PASSED. NO LEAKS FOUND. OPTICAL READING UNIT (ORU) REFERENCE READINGS IN RANGE AND STABLE. LIQUID LEVEL DETECTION (LLD) COUNTS FOR BOTH PROBES WERE NORMAL AND STABLE. COORDINATE DELTAS WERE LOW AND STABLE. NO INSTRUMENT RELATED ISSUES WERE IDENTIFIED. SINCE THE AFFECTED SAMPLE IS NOT AVAILABLE TO PERFORM TESTING, NO FURTHER INVESTIGATIONAL TESTING CAN BE DONE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE (IFU) OF THE PRODUCT REPORTS A TOTAL PERCENTAGE AGREEMENT OF 82% IN METHOD COMPARISON AND 90% IN EXTERNAL VALIDATION, VS ELISA ASSAY, 87% VS SRA. THESE FIGURES SUGGEST THAT DISCREPANCIES MAY ARISE IN SPECIFIC SAMPLES WHEN COMPARING HEMOSIL HIT-AB(PF4-H) WITH OTHER METHODOLOGIES. FOR THIS REASON, THE IFU STATES THAT CONFIRMATION OF RESULTS WITH A FUNCTIONAL TEST IS RECOMMENDED AND THAT THE ASSAY RESULTS SHOULD BE USED WITH OTHER INFORMATION, INCLUDING THE CLINICAL CONTEXT IN FORMING A DIAGNOSIS. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.

    Description of Event or Problem · 0

    A COMPLAINT HAS BEEN FILED FOR A DISCREPANT HIT TEST RESULT. THE PATIENT SAMPLE ID (B)(6), TESTED ON THE ACL TOP USING REAGENT/CALIBRATOR PN 00020014600, YIELDED A NEGATIVE RESULT. THE SAME SAMPLE, WHEN SENT TO MAYO CLINIC, RETURNED A POSITIVE SRA RESULT (CUT-OFF: >0.400 POSITIVE). THE SAMPLE WAS INITIALLY SENT TO MAYO AFTER PHARMACY QUESTIONED THE NEGATIVE RESULT, GIVEN THE PATIENT'S CLINICAL HISTORY OF A LEFT APICAL THROMBUS, STROKE, AND SUBSEQUENT DEATH UNDER PALLIATIVE CARE. THE SITE HAS NOW DISCONTINUED HIT TESTING ON THE ACL TOP AND IS SENDING SAMPLES TO QUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362089 HEMOSIL HIT- AB(PF4-H) PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO INSTRUMENTATION LABORATORY CO. B37250 08426950975380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death