BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 15639790 · Received October 20, 2022

    Report

    Report Number
    3005094123-2022-00227
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 1, 2022
    Report Date
    January 30, 2023
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02R98.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. THE TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TREND REGARDING COMMONALITIES FOR LOT NUMBERS AND ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA THROUGH ABBOTTLINK. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOTS (REVIEWED WITH AT LEAST 10,000 DATA POINTS) IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOTS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 0

    A PROVIDED LITERATURE ARTICLE BY BRUINEN, ANNE L. ET AL., ¿POINT-OF-CARE HIGH-SENSITIVITY TROPONIN-I ANALYSIS IN CAPILLARY BLOOD FOR ACUTE CORONARY SYNDROME DIAGNOSTICS¿, CLINICAL CHEMISTRY AND LABORATORY MEDICINE 60.10: 1669-1674. DE GRUYTER OPEN LTD. (SEP 1, 2022), DOCUMENTED A VALIDATION STUDY FOR THE ATELLICA® VTLI PATIENT-SIDE IMMUNOASSAY ANALYZER FOR HIGH-SENSITIVITY POC CARDIAC TROPONIN-I (HS-CTNI) AND COMPARED TEST RESULTS TO ON ARCHITECT TROPONIN-I, STAT HIGH SENSITIVE AND THE ROCHE METHOD. THE STUDY DOCUMENTED TWO INCIDENTS OF FALSE NEGATIVE ARCHITECT TROPONIN-I, STAT HIGH SENSITIVE RESULTS FOR PATIENT 1 AND PATIENT 2 WHEN COMPARED TO THE ROCHE METHOD AND THE POC METHOD. PATIENT 1 WAS AN 88-YEAR-OLD FEMALE WITH CHEST PAIN AND SLIGHT RISE OF ARCHITECT TROPONIN-I, STAT HIGH SENSITIVE RESULTS. PULMONARY EMBOLI AND AORTIC DISSECTION WERE RULED OUT. THE ROCHE TROPONIN-T CONCENTRATION ROSE TO 34 NG/L THE NEXT DAY, BUT THE PATIENT DID NOT HAVE ANY COMPLAINTS. ORAL ANTIANGINAL DRUGS WERE PRESCRIBED, SHE WAS DISCHARGED AND A SPECT SCAN AT THE OUTPATIENT CLINIC SHOWED NON-SIGNIFICANT PERFUSION DEFECTS AND NO SIGNS OF LEFT VENTRICLE DYSFUNCTION. ARCHITECT TROPONIN-I, STAT HIGH SENSITIVE RESULT WAS 22.6 NG/L (CUTOFF 26.2 NG/L), ROCHE RESULT WAS 23 NG/L (CUTOFF 14 NG/L), ATELLICA VTLI POC RESULT WAS 24.3 NG/L (CUTOFF 22.9 NG/L). PATIENT 2 WAS A 65-YEAR-OLD FEMALE PATIENT PRESENTING TO THE ED WITH TYPICAL CHEST PAIN. ACS WAS RULED OUT BASED ON THE ROCHE RESULTS. ARCHITECT TROPONIN-I, STAT HIGH SENSITIVE RESULT WAS <2.0 NG/L (CUTOFF 26.2 NG/L), ROCHE RESULT WAS 6 NG/L (CUTOFF 14 NG/L), ATELLICA VTLI POC RESULT WAS 110.9 NG/L (CUTOFF 22.9 NG/L). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147098 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, 116UNKNOWN11.| ARC I2000SR INST, 03M74-02, 116UNKNOWN11.