BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 16248732 · Received January 26, 2023

    Report

    Report Number
    3016438761-2023-00043
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    November 28, 2022
    Report Date
    February 17, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, AND MANUFACTURING SITE OF NEW SUSPECT DEVICE (ABBOTT LABORATORIES) BACK TO THE ALINITY I TOXO IGG REAGENT KIT, LIST NUMBER 07P45-32, AND MANUFACTURING SITE IN SECTION D OF THIS REPORT (ABBOTT GMBH). MDR NUMBER 3002809144-2022-00423-02 (LIST 07P45-32, LOT 44254BE00) AND MDR NUMBER 3002809144-2023-00071-00 (LIST 07P45-32, LOT 46257BE00) HAVE BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THOSE MDR NUMBERS.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2022-00423-00 UNDER A DIFFERENT SUSPECT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I TOXO IGG RESULTS FOR THREE PATIENTS COMPARED TO RESULTS ON ANOTHER INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): 1ST PASS: (B)(4) 2.064 IU/ML, 2ND PASS: (B)(4) 0.401 IU/ML. SID (B)(6): 1ST PASS: (B)(4) 8.2558 IU/ML, 2ND PASSAGE: (B)(4), 0.266 IU/ML. SID (B)(6): 1ST VISIT: (B)(4), 10.633 IU/ML, 2ND PASS: (B)(4), 0.132 IU/ML. SID (B)(6): 1ST PASSAGE: 12.38 IU/ML (B)(4), ON (B)(6) 2023, 2ND PASSAGE: 0.14 IU/ML (B)(4) ON (B)(6) 2023. (B)(6): 1ST PASSAGE: 2.75 IU/ML (B)(4), ON (B)(6) 2023, 2ND PASSAGE: 0.09 IU/ML (B)(4), ON (B)(6) 2023. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203376 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 TOXO IGG 1000 T, 07P45-32, 44254BE00| ALNTY I TOXO IGG 1000 T, 07P45-32, 44254BE00| ALNTY I TOXO IGG 1000 T, 07P45-32, 46257BE00| ALNTY I TOXO IGG 1000 T, 07P45-32, 46257BE00