BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 20567375 · Received October 30, 2024

    Report

    Report Number
    3016438761-2024-00636
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02, ABBOTT LABORATORIES, IRVING, TEXAS, USA TO ARCHITECT PROLACTIN REAGENT, LIST 07K76-25, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND. MDR NUMBERS 3005094123-2024-00604 AND 3005094123-2024-00605 HAVE BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THOSE MDR NUMBERS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS SENT OUT FOR A RETEST AND THE RESULT WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 4 TO 26 NG/ML 03OCT2024 SID (B)(6) ARCHITECT PROLACTIN RESULT = 33.69 NG/ML RETEST RESULT FROM ANOTHER LAB = 24.5 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020517 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC PROLACTIN RGT 100T, 07K76-25, 61393UD00.| ARC PROLACTIN RGT 100T, 07K76-25, 61393UD00.