BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 13691408 · Received March 8, 2022

    Report

    Report Number
    3005094123-2022-00039
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 22, 2022
    Report Date
    June 9, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST 3P25, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST 2R98. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW OF COMPLAINT DATA FOR THE LIKELY CAUSE LIST NUMBER DOES NOT IDENTIFY ANY ADVERSE TREND. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR THE LOT NUMBER USING SEARCH OF THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 32056UD00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. AS REVIEW OF APPLICABLE FIELD DATA SUGGESTS THAT THE PERFORMANCE IS ACCEPTABLE, FILE KIT TESTING IS NOT PERFORMED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    UPDATE TO H.6. MEDICAL DEVICE PROBLEM CODE, IS UPDATED FROM A090804 TO THE CORRECT CODE OF A090809.UPDATE TO H.6. MEDICAL DEVICE PROBLEM CODE, IS UPDATED FROM A090804 TO THE CORRECT CODE OF A090809.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ON PATIENT SAMPLE THAT REPEATED NEGATIVE. THE PATIENT IS A (B)(6) YEAR OLD FEMALE (RACE/ETHNICITY IS (B)(6) WITH SYSTEMIC LUPUS ERYTHEMATOSUS, NORMAL COAGULATION ITEMS AND NORMAL BIOCHEMICAL INDICATORS. THE SAMPLE GENERATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I OF 1894 PG/ML BUT REPEATED 0.5, 0.7, 0.7, 0.8 NG/ML. THE ACCOUNT USES A REFERENCE RANGE OF 0 TO 26.2 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932272 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 32056UD01

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ARC I2000SR INST, 03M74-02, (B)(6).| ARC I2000SR INST, 03M74-02, (B)(6).