BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT

    MDR report key: 13906229 · Received March 25, 2022

    Report

    Report Number
    3005094123-2022-00055
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 21, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    UDI-DI
    00380740175504
    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

    ALL AVAILABLE PATIENT INFORMATION IS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THE PRODUCT. TRACKING AND TRENDING WERE REVIEWED AND DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. IN-HOUSE TESTING WAS COMPLETED WITH A REAGENT KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT(S) AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY FOR ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 35249UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A PATIENT SAMPLE WHILE RUNNING ON THE ARCHITECT I2000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2022 SID (B)(6): INITIAL TROPONIN-I RESULT: 116 NG/L (CUSTOMER¿S CUTOFF > 35NG/L; REPEAT ON ANOTHER ARCHITECT: 7.4 NG/L; RE-CENTRIFUGED SAMPLE AND REPEATED ON ORIGINAL ANALYZER: 7.8 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128347 ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 02R9835 35249UD00 00380740175504

    Patients

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