BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 12540847 · Received September 28, 2021

    Report

    Report Number
    3005094123-2021-00185
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 12, 2021
    Report Date
    November 22, 2021
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT SEARCH REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE FOR THE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH LOT NUMBER 30254UD00 AND THE COMPLAINT ISSUE. THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY WAS ASSESSED USING WORLD-WIDE FIELD DATA AND SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 30254UD00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOTS. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 30254UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A PHYSICIAN WAS QUESTIONING FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (FEMALE REFERENCE RANGE <16 PG/ML): ON (B)(6) 2021 SAMPLE (B)(6). INITIAL RESULT WAS 136 PG/ML, REPEATS 98 / 584 / 1745 / <5 / <5 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437083 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 30254UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, ISR07891