BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 14242144 · Received April 28, 2022

    Report

    Report Number
    3016438761-2022-00179
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    February 13, 2022
    Report Date
    April 28, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2022-00034-00 UNDER A DIFFERENT SUSPECT DEVICE. ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) INVESTIGATED THE ISSUE ON SITE. FSR OBSERVED CRYSTALS ON THE ALNTY I BAFFLE WC (04S62-02), CLEANED THE ALNTY BAFFLE WC WHICH RESOLVED THE ISSUE. A REVIEW OF THE ALINITY I ANALYZER, SERIAL NUMBER (B)(4) SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. THERE HAVE BEEN NO ADDITIONAL DISCREPANT PATIENT RESULTS DOCUMENTED SINCE THE ALNTY I BAFFLE WC (04S62-02) WAS CLEANED. THE ALINITY CI-SERIES OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO CONTAINS INFORMATION FOR MANUAL CLEANING OF THE WASH CUP AS PART OF WEEKLY MAINTENANCE TO REMOVE SALT BUILD UP FROM THE ALNTY I BAFFLE WC (04S62-02). A REVIEW OF HISTORICAL DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS WITH REGARDS TO THE CURRENT ISSUE. A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I ANALYZER, SERIAL NUMBER (B)(4) OR THE ALNTY BAFFLE WC.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS ON TWO PATIENTS WHICH DOES NOT MATCH WITH PATIENT¿S ACTUAL CONDITION. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) =36.61 MIU/ML (> OR = 25.00 MIU/ML=POSTITIVE) /REPEATED ON (B)(6) 2022= < 2.3 MIU/ML (< OR =5.0 MIU/ML=NEGATIVE). ON (B)(6) 2022 SID (B)(6)=50.94 MIU/ML /REPEATED ON (B)(6) 2022=< 2.3 MIU/ML LABORATORY REFERENCE RANGE FOR B-HCG= < 5.0 MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119497 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALIN I BHCG 1200T (CN), 07P51-77, 31036UD01