BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SYSTEM

    MDR report key: 13447461 · Received February 3, 2022

    Report

    Report Number
    3005248192-2022-00146
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 19, 2022
    Report Date
    February 3, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT CONCLUDED IT WAS RELATED TO A PREVIOUSLY CONFIRMED INVESTIGATION. COMPLAINT DOCUMENTS COMPLETION OF TSB 640-139 AND CLEARLY INDICATED ADJUSTED OR FAILED FOR THE ADU BOARD VALUES. URGENT FIELD SAFETY NOTICE / FIELD CORRECTION RECALL (FA-AM-DEC2021-263) AND A TECHNICAL SERVICE BULLETIN WERE ISSUED DECEMBER 6, 2021 TO ADDRESS THIS ISSUE. IT WAS DEEMED REPORTABLE PER 21CFR 806 AND THEREFORE REPORTABLE UNDER 21CFR803. THIS ACTION WAS COMMUNICATED TO THE FDA ON NOVEMBER 6, 2021. THE FOLLOWING MDRS WERE ALSO REPORTED AS RELATED TO FA-AM-DEC2021-263 (482-RISK): 3005248192-2021-00115 FOLLOW UP REPORT 1 3005248192-2021-00443, 3005248192-2021-00445, 3005248192-2021-00508, 3005248192-2021-00509, 3005248192-2021-00510, 3005248192-2021-00511, 3005248192-2021-00512, 3005248192-2021-00513, 3005248192-2021-00514, 3005248192-2021-00515, 3005248192-2021-00516, 3005248192-2021-00517, 3005248192-2021-00518, 3005248192-2021-00519, 3005248192-2021-00520, 3005248192-2021-00521, 3005248192-2021-00522, 3005248192-2021-00523, 3005248192-2021-00524, 3005248192-2021-00525, 3005248192-2022-00013, 3005248192-2022-00014, 3005248192-2022-00015, 3005248192-2022-00018, 3005248192-2022-00020, 3005248192-2022-00021, 3005248192-2022-00022, 3005248192-2022-00025, 3005248192-2022-00026, 3005248192-2022-00027, 3005248192-2022-00028, 3005248192-2022-00029, 3005248192-2022-00033, 3005248192-2022-00034, 3005248192-2022-00035, 3005248192-2022-00036, 3005248192-2022-00037, 3005248192-2022-00038, 3005248192-2022-00039, 3005248192-2022-00040, 3005248192-2022-00041, 3005248192-2022-00042, 3005248192-2022-00043, 3005248192-2022-00058, 3005248192-2022-00059, 3005248192-2022-00060, 3005248192-2022-00061, 3005248192-2022-00062, 3005248192-2022-00071, 3005248192-2022-00072, 3005248192-2022-00073, 3005248192-2022-00074, 3005248192-2022-00075, 3005248192-2022-00076, 3005248192-2022-00078, 3005248192-2022-00079, 3005248192-2022-00080, 3005248192-2022-00081, 3005248192-2022-00082, 3005248192-2022-00083, 3005248192-2022-00084, 3005248192-2022-00085, 3005248192-2022-00086, 3005248192-2022-00087, 3005248192-2022-00088, 3005248192-2022-00089, 3005248192-2022-00090, 3005248192-2022-00091, 3005248192-2022-00092, 3005248192-2022-00093, 3005248192-2022-00094, 3005248192-2022-00096, 3005248192-2022-00097, 3005248192-2022-00098, 3005248192-2022-00099, 3005248192-2022-00100, 3005248192-2022-00103, 3005248192-2022-00104, 3005248192-2022-00105, 3005248192-2022-00107, 3005248192-2022-00108, 3005248192-2022-00109, 3005248192-2022-00110, 3005248192-2022-00111, 3005248192-2022-00112, 3005248192-2022-00113, 3005248192-2022-00117, 3005248192-2022-00118, 3005248192-2022-00119, 3005248192-2022-00126, 3005248192-2022-00127, 3005248192-2022-00128, 3005248192-2022-00129, 3005248192-2022-00130, 3005248192-2022-00131, 3005248192-2022-00132, 3005248192-2022-00145.

    Description of Event or Problem · 0

    TICKET IS RELATED TO EXECUTION OF TSB 640-139, AMP-DETECT OPTICAL ADJUSTMENT UPGRADE PROCEDURE, WHICH IS PERFORMED TO UPGRADE MAINTENANCE AND DIAGNOSTICS (M&D) 2303 ON THE ALINITY M SYSTEM AND TO PERFORM AN ANALYSIS OF THE AMP-DETECT UNITS (ADUS) TO DETERMINE IF THE BOARD VALUES ARE CORRECT. FOR THIS SERIAL NUMBER AMP DETECT UNITS (ADU) 3 AND 4 INDICATED FAIL AND ADJUSTED, RESPECTIVELY. ISSUE IS ASSOCIATED WITH REPORTABLE FIELD ACTION (FA-AM-DEC2021-263). THERE IS NO PATIENT INVOLVED WITH THIS MDR AS THE BOARD ADJUSTMENT WAS PERFORMED BY THE ABBOTT FIELD SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593991 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 08N53-002 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown