BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 10129363 · Received June 8, 2020

    Report

    Report Number
    3005094123-2020-00119
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 18, 2020
    Report Date
    July 21, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, LIST NUMBER, 03P25-37 AND MANUFACTURING SITE ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD, TO ARCHITECT I2000SR ANALYZER, LIST NUMBER 03M74-97, AND MANUFACTURING SITE ABBOTT LABORATORIES (IRVING IA/CC). MDR NUMBER 3016438761-2020-00125 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. PROVIDED IN MDR # 3016438761-2020-00125.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: PT#1: (B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY RESULTS FOR FOUR PATIENTS. THE CUSTOMER PROVIDED: SID: (B)(6) INITIAL = < 1.1 NG/L, REPEAT =15.9 NG/L; SID: (B)(6) INITIAL = <1.1 NG/L, REPEAT = 6.9 NG/L; SID: (B)(6) INITIAL = <1.1 NG/L, REPEAT =126.3 NG/L; SID: (B)(6) INITIAL = < 1.1 NG/L, 99.7 NG/L (OVERALL POPULATION CUT OFF = 26.2 NG/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591019 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I TROPONIN-I MMI ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD 13157UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER,| ARCHITECT I2000SR ANALYZER,| LN 03M74-97, SN (B)(4)| LN 03M74-97, SN (B)(4)