BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSIL HIT- AB(PF4-H)

    MDR report key: 19160534 · Received April 22, 2024

    Report

    Report Number
    1217183-2024-00002
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    February 6, 2024
    Report Date
    June 11, 2024
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    LCO
    UDI-DI
    08426950975380
    PMA / PMN Number
    K153137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. INVESTIGATION IS ONGOING. THE REPORTABILITY IS BASED ON THE ASSESSMENT THAT TREATMENT COULD HAVE CHANGED BASED ON THE NEGATIVE RESULT AND POTENTIALLY CAUSED HARM.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS SUBMITTED ON HEMOSIL HIT-AB (PF4-H) PN 00020014600 LOT B36074 INDICATING THAT A FALSE NEGATIVE RESULT WAS GENERATED BY ACL TOP 700 SN (B)(6). SAMPLE ID (B)(6) WAS RUN 02/06/2024 13:35:26 AND PRODUCED A HIT-AB RESULT OF 0.8 U/ML. THE SAMPLE WAS REPEATED ON ANOTHER ACL TOP INSTRUMENT AND PRODUCED A NEGATIVE RESULT. THE PATIENT WAS SUSPECTED OF HIT; THEREFORE, ELISA AND SRA TESTING WAS PERFORMED AND YIELDED POSITIVE RESULTS. NO CORRECTED REPORT WAS ISSUED AS ONLY THE POSITIVE RESULT WAS RELEASED TO THE CHART. THERE WAS NO PATIENT IMPACT. REVIEW OF THE SUBMITTED DATA IDENTIFIED THE SAMPLES THAT THE CUSTOMER REPORTED. THE INSTRUMENT WAS PERFORMING TO SPECIFICATIONS DURING SAMPLE ANALYSIS AS INDICATED IN THE INSTRUCTIONS FOR USE. MANUFACTURING AND QC DATA FROM HEMOSIL HIT-AB (PF4-H) LOT B36074 WAS REVIEWED. NEITHER ISSUES NOR TRENDS WERE IDENTIFIED WITH THE IMPACTED LOT. ACCORDING TO THE RESULTS REVIEWED, NO DEFICIENCY IS IDENTIFIED FOR HEMOSIL HIT-AB (PF4-H) LOT B36074. BASED ON THE ABOVE, THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION OR DEFICIENCY OF THE REAGENT.. NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TWO COMPLAINTS REGARDING A NEGATIVE RESULT FOR HIT-AB RUN ON TWO SEPARATE ACL TOP 700 INSTRUMENTS. A SEPARATE REPORT (1217183-2024-00003) HAS BEEN FILED FOR THE SAMPLE ANALYZED ON ACL TOP 700 SERIAL NUMBER (B)(6). IT WAS REPORTED THAT A PATIENT SUSPECTED OF HIT RECEIVED A NEGATIVE RESULT ON THE ACL TOP 700 SERIAL NUMBER (B)(6). OTHER METHODS OF TESTING (ELISA AND SRA) WERE POSITIVE. THE CUSTOMER CONSIDERS THE NEGATIVE RESULT FROM THE ACL TOP 700 ERRONEOUS. THE NEGATIVE RESULT FROM THE ACL TOP 700 WAS NOT REPORTED, AS THE POSITIVE ELISA TEST FIT THE PATIENT'S PROFILE. NO CORRECTED REPORT WAS ISSUED AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083786 HEMOSIL HIT- AB(PF4-H) PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO INSTRUMENTATION LABORATORY CO. B36074 08426950975380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown