BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSIL ACUSTAR

    MDR report key: 8305305 · Received February 5, 2019

    Report

    Report Number
    1217183-2019-00002
    Event Type
    Death
    Date Received
    February 5, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 5, 2019
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    JPA
    UDI-DI
    08426950498001
    PMA / PMN Number
    K170314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE HEMOSIL ACUSTAR ANTI-CARDIOLIPIN IGG ASSAY ADVISES THAT DEFINITIVE CLINICAL DIAGNOSIS CANNOT BE MADE ON THE BASIS OF AN ACL IGG POSITIVE RESULT ALONE, AND PATIENT HISTORY AND CLINICAL FINDINGS MUST BE CONSIDERED. AN INVESTIGATION IS CURRENTLY IN PROGRESS AND A FOLLOW-UP REPORT WILL BE FILED UPON CONCLUSION OF THE INVESTIGATION. FOLLOW UP NARRATIVE FEBRUARY 12, 2019: AN INVESTIGATION WAS CONDUCTED THAT INCLUDED REVIEW OF THE HEMOSIL ANTI-CARDIOLIPIN IGG (ACL IGG) PERFORMANCE ON THE ACL ACUSTAR. AS PART OF THIS INVESTIGATION, BATCH RECORDS FOR ACL IGG FOR THE PAST TWO YEARS WERE REVIEWED AND THE FUNCTIONAL QUALITY CONTROL (QC) RESULTS WERE DETERMINED TO BE CONSISTENT FROM LOT-TO-LOT. FURTHER, SAMPLES RUN DURING THE FUNCTIONAL QC WERE RE-TESTED WITH THE ACL IGG COMPLAINT LOT AND RESULTS WERE CONSISTENT WITH THE ORIGINAL RELEASE DATA AND THE CORRELATION COEFFICIENT MET THE SPECIFICATION CRITERIA. NOTE: PATIENT SPECIFIC DATA AND THE INSTRUMENT DATABASE WERE NOT PROVIDED BY THE CUSTOMER FOR THE INVESTIGATION. BASED ON THE ABOVE, HEMOSIL ANTI-CARDIOLIPIN IGG (ACL IGG) ON THE ACL ACUSTAR IS MEETING SPECIFICATION AND NO REMEDIAL ACTION IS INDICATED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT TWO PREGNANT PATIENTS WERE DIAGNOSED WITH ANTIPHOSPHOLIPID SYNDROME BASED ON A POSITIVE ANTI-CARDIOLIPIN IGG (ACL IGG) RESULTS ON THE ACL ACUSTAR AND SUBSEQUENTLY TREATED WITH LOW MOLECULAR WEIGHT HEPARIN AND ACETYLSALICYLIC ACID/ASPIRIN. DURING THEIR PREGNANCY, EACH WOMAN DEVELOPED A UTERINE HEMATOMA. ANTICOAGULATION THERAPY WAS STOPPED AFTER HEMATOMAS OCCURRED. ADDITIONALLY, ONE OF THE PATIENTS ALSO EXPERIENCED A SPONTANEOUS ABORTION AT 7-8 WEEKS OF GESTATION; HOWEVER, THE CUSTOMER INDICATED THAT IT WAS NOT POSSIBLE TO DEFINITELY DETERMINE THE UNDERLYING CAUSE OF THE ABORTED PREGNANCY, AS SHE WAS A HIGH-RISK PATIENT WITH PREVIOUS MISCARRIAGES.

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE FOR THE HEMOSIL ACUSTAR ANTI-CARDIOLIPIN IGG ASSAY ADVISES THAT DEFINITIVE CLINICAL DIAGNOSIS CANNOT BE MADE ON THE BASIS OF AN ACL IGG POSITIVE RESULT ALONE, AND PATIENT HISTORY AND CLINICAL FINDINGS MUST BE CONSIDERED. AN INVESTIGATION IS CURRENTLY IN PROGRESS AND A FOLLOW-UP REPORT WILL BE FILED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO PREGNANT PATIENTS WERE DIAGNOSED WITH ANTIPHOSPHOLIPID SYNDROME BASED ON A POSITIVE ANTI-CARDIOLIPIN IGG (ACL IGG) RESULTS ON THE ACL ACUSTAR AND SUBSEQUENTLY TREATED WITH LOW MOLECULAR WEIGHT HEPARIN AND ACETYLSALICYLIC ACID/ASPIRIN. DURING THEIR PREGNANCY, EACH WOMAN DEVELOPED A UTERINE HEMATOMA. ANTICOAGULATION THERAPY WAS STOPPED AFTER HEMATOMAS OCCURRED. ADDITIONALLY, ONE OF THE PATIENTS ALSO EXPERIENCED A SPONTANEOUS ABORTION AT (B)(6) OF GESTATION; HOWEVER, THE CUSTOMER INDICATED THAT IT WAS NOT POSSIBLE TO DEFINITELY DETERMINE THE UNDERLYING CAUSE OF THE ABORTED PREGNANCY, AS SHE WAS A HIGH-RISK PATIENT WITH PREVIOUS MISCARRIAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100494 HEMOSIL ACUSTAR ACL ACUSTAR JPA INSTRUMENTATION LABORATORY 08426950498001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death