BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEG 6S HEMOSTASIS SYSTEM CITRATED K, KH, RT, FF

    MDR report key: 15949643 · Received December 9, 2022

    Report

    Report Number
    1219343-2022-00056
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 14, 2022
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K150041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES HAVE NOT BEEN RETURNED TO HAEMONETICS FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME; IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A DEFECT RELATED TO MANUFACTURING WITHOUT A SAMPLE FOR EVALUATION. THE AUTOMATED TEG 6S HEMOSTASIS ANALYZER IS A NON-INVASIVE DIAGNOSTIC INSTRUMENT DESIGNED TO MONITOR AND ANALYZE THE COAGULATION STATE OF A BLOOD SAMPLE IN ORDER TO ASSIST IN THE ASSESSMENT OF A PATIENT'S HEMOSTATIC STATUS AND ITS CLINICAL IMPLICATIONS. THE TEG 6S ANALYZER IS INDICATED FOR USE WITH ADULT PATIENTS WHERE A DYNAMIC EVALUATION OF BLOOD COAGULATION AND HEMOSTATIC PROPERTIES IS DESIRED. ACCORDING TO THE EARLY ANALYSIS OF THE DATA SHARED BY THE CUSTOMER, THE LY30 AND MA PARAMETERS ARE AFFECTED. THOSE 2 PARAMETERS ARE USED BY THE PRACTITIONER AS DECISION PARAMETERS. IF USED IN ISOLATION, ERRONEOUS VALUES COULD LEAD TO MISDIAGNOSIS OF HYPER/HYPOCOAGULABLE. THE PRODUCT DOCUMENTATION WARNS AGAINST USING ANY PARAMETER IN ISOLATION. THE LY30 ISSUES THAT THE CUSTOMER IS EXPERIENCING IS ESTIMATED TO HAVE A POTENTIAL IMPACT ON THE TREATMENT RECEIVED BY A PATIENT. HARM IS CONSIDERED POSSIBLE BUT UNLIKELY DUE TO MITIGATIONS IN PLACE. ALSO, THERE HAVE NOT BEEN ANY REPORTS OF PATIENT MIS-DIAGNOSIS DUE TO ABNORMAL LY30 READINGS. CLINICIANS ARE PROVIDED GUIDANCE BY HAEMONETICS TO NOT TREAT ACCORDING TO A SINGLE PARAMETER, AND TO DEVELOP A COMPREHENSIVE TREATMENT PLAN ACCORDING TO THE PATIENTS' OVERALL, HOLISTIC HEALTH. RESULTS FROM THE TEG 6S SYSTEM SHOULD NOT BE THE SOLE BASIS FOR A PATIENT DIAGNOSIS BUT SHOULD BE EVALUATED TOGETHER WITH THE PATIENT'S MEDICAL HISTORY, THE CLINICAL PICTURE AND, IF NECESSARY, OTHER COAGULATION TESTS. IN ADDITION, OUR GUIDANCE ALSO INSTRUCTS THE CLINICIANS TO ESTABLISH THEIR OWN ACCEPTABLE REFERENCE RANGES FOR CK-LY30 AND HOW IT ALIGNS WITH MA. BECAUSE THERE IS A POSSIBILITY, ALTHOUGH REMOTE, OF A MIS-DIAGNOSIS, IT WAS DECIDED TO REPORT THIS ISSUE.

    Description of Event or Problem · 0

    ON NOVEMBER 14, 2022, HAEMONETICS WAS MADE AWARE THAT "BUMPS AND STRANGE CURVES ON ALMOST EVERY SECOND RUN WE DO (SOMETIMES EVEN MORE)". CUSTOMER REPORTED HIGH LYSIS TRACINGS RESEMBLING ERRONEOUS LY30 RESULTS WHEN USING THE TEG6S CITRATED: K, KH, RT, FF TEST ANALYZER. THIS EVENT DID NOT OCCUR DURING A PROCEDURE AND NO PATIENT WAS INVOLVED. BECAUSE THERE IS A POSSIBILITY, ALTHOUGH REMOTE, OF A MIS-DIAGNOSIS, IT WAS DECIDED TO REPORT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596800 TEG 6S HEMOSTASIS SYSTEM CITRATED K, KH, RT, FF TEG 6S HEMOSTASIS SYSTEM CITRATED K, KH, RT, FF JPA HAEMONETICS CORPORATION C420714227, C420718225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown