BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 13801341 · Received March 17, 2022

    Report

    Report Number
    3016438761-2022-00116
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 17, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT IDENTIFIER, DEMOGRAPHIC INFORMATION OR PATIENT RESULTS WERE PROVIDED. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND REPLACED THE SHUTTER ASSEMBLY (PART NUMBER A-30104913-04), CIRCUIT BOARD, CIRCUIT BOARD, TEMP-OPTICS CONTROLLER (PART NUMBER A-90001090-01) AND CMIA READER, METAL CASE, TESTED (PART NUMBER 7-201909-03) WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ALINITY I, SERIAL NUMBER AI21554 REVEALED NO ADDITIONAL ISSUES OF FALSE POSITIVE SYPHILIS RESULTS REPORTED ON THE ALINITY I AI21554 POST SERVICE INTERVENTION FOR THE CURRENT TICKET. A REVIEW OF TRACKING AND TRENDING FOR THE SHUTTER ASSEMBLY (PART NUMBER A-30104913-04), CIRCUIT BOARD, CIRCUIT BOARD, TEMP-OPTICS CONTROLLER (PART NUMBER A-90001090-01) AND CMIA READER, METAL CASE, TESTED (PART NUMBER 7-201909-03) DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I/ARCHITECT IA DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE SHUTTER ASSEMBLY (PART NUMBER A-30104913-04), CIRCUIT BOARD, CIRCUIT BOARD, TEMP-OPTICS CONTROLLER (PART NUMBER A-90001090-01) AND CMIA READER, METAL CASE, TESTED (PART NUMBER 7-201909-03) OR THE ALINITY I, SERIAL NUMBER (B)(4) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER IDENTIFIED FALSE POSITIVE ALINITY I SYPHILIS TP RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644865 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I SYPHILIS 200 TE, 07P60-22, 31608BE00