BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 13237102 · Received January 12, 2022

    Report

    Report Number
    3005094123-2022-00013
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 22, 2021
    Report Date
    January 25, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    MMI
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98.

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD-WIDE DATA THROUGH ABBOTTLINK WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 31409UD00 WAS ANALYZED AND FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUES FOR THIS LOT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, LOT 31409UD00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ON AN (B)(6) OLD MALE PATIENT. RESULTS PROVIDED: (B)(6) 2021 = 2162 / 2200 PG/ML. OTHER RESULTS PROVIDED: CK: (B)(6) 2021 = 122 U/L, (B)(6) 2021 = 464 U/L, (B)(6) 2021 = 123 U/L; BNP: (B)(6) 2021 = 441.2 PG/ML, (B)(6) 2021 = 476.2 PG/ML, (B)(6) 2021 = 528.6 PG/ML; ELECTROCARDIOGRAM IS NORMAL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101067 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI A.I.D.D LONGFORD 31409UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male ARC I1000SR MOD, 01L86-01, I1SR61703| ARC I1000SR MOD, 01L86-01, I1SR61703