BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT

    MDR report key: 16495511 · Received March 7, 2023

    Report

    Report Number
    3005094123-2023-00063
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    January 20, 2023
    Report Date
    August 28, 2023
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    UDI-DI
    00380740175498
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION NEEDED FOR SECTION D4 CATALOG # SHOULD BE 02R98-35 AND NOT 02R98-25.

    Additional Manufacturer Narrative · 0

    1415939-2023-00009-01 G3 WAS INCORRECTLY ENTERED AS 1/23/2023 AND SHOULD HAVE BEEN ENTERED AS 02/28/2023 (THE DATE THE LIKELY CAUSE WAS CHANGED). 1415939-2023-00009-02 G3 WAS INCORRECTLY ENTERED AS 2/28/2023 AND SHOULD HAVE BEEN ENTERED AS 04/03/2023 (DATE THE CORRECTION WAS IDENTIFIED).

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 44462UD00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2023-00009-01 UNDER A DIFFERENT SUSPECT DEVICE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION D: SUSPECT MEDICAL DEVICE INFORMATION: D4: CATALOG NUMBER UPDATED FROM 02R98-25 TO 02R98-35.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT SAMPLE ON THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED AND THE RESULT WAS IN THE CUSTOMERS NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 21 NG/L, REPEAT RESULTS ON ISR64746 <4, <4, AND <4 RESULT FROM ANOTHER ANALYZER = <4 NG/L CUSTOMER¿S REFERENCE RANGE IS <4 = NORMAL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61267 ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 02R9825 44462UD00 00380740175498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)