BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 13257818 · Received January 14, 2022

    Report

    Report Number
    3005094123-2022-00016
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 24, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. MORE FOLLOW-UP SAMPLE RESULTS WERE OBTAINED. A NEW SAMPLE WAS OBTAINED FOR THE SAME PATIENT. HSTNI ABBOTT UNILABS SID: (B)(6) 582 NG/L (B)(6) 2022, SID: (B)(6) 1435 NG/L (B)(6) 2022, SID: (B)(6) 717 NG/L (B)(6) 2022, HSTNT ROCHE USZ: 22 NG/L (B)(6) 2022. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LIST NUMBER AND THE COMPLAINT ISSUE. THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING REVIEWED USING WORLDWIDE FIELD DATA. THE LOT IS UNKNOWN IN THIS CASE, HOWEVER THE REVIEW PERFORMED INDICATES THAT THE ON MARKET LOTS ARE COMPARABLE AND PERFORMING ACCEPTABLY IN THE FIELD. LITERATURE REVIEW PERFORMED INDICATES THAT ELEVATED TROPONIN LEVELS CAN OCCUR IN PATIENTS WITH COVID-19. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. PER PRODUCT LABELING FOR MI DIAGNOSTIC PURPOSES, THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER INFORMATION SUCH AS ECG, CLINICAL OBSERVATIONS, AND SYMPTOMS, ETC. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO GENERAL ISSUE WITH THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (ARCHITECT REFERENCE RANGE <26 NG/L, ROCHE REFERENCE RANGE <14 NG/L): (B)(6) 2021 SID (B)(6) ARCHITECT RESULT WAS 1026 NG/L, REPEATED 924 NG/L; ROCHE RESULT WAS 3 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627093 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 I2SR REFURB-SEKAT, 03M74-97, ISR01988| ARC I2SR REFURB-SEKAT, 03M74-97, ISR01988