BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 15824572 · Received November 18, 2022

    Report

    Report Number
    3016438761-2022-00538
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 8, 2022
    Report Date
    January 10, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    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

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

    Additional Manufacturer Narrative · 0

    SERVICE PERFORMED THE EXTENSIVE TROUBLESHOOTING, MULTIPLE PARTS WERE REPLACED, CLEANED AND CALIBRATED/ AND OR ADJUSTED. HOWEVER, THE NOZZLE C4 #1, #4, #5 (ROHS)_ AND NOZZLE, #2 AND #3 (ROHS)_ WERE DEEMED THE CAUSE. THE REPLACEMENT OF THE NOZZLE C4 #1, #4, #5 (ROHS) AND NOZZLE, #2 AND #3 (ROHS) WERE CONSIDERED ISSUE RESOLUTION FOR THE FALSELY ELEVATED CREATININE RESULT. THE MODULE FUNCTION WAS VERIFIED WITH A CONTROL/PRECISION RUN. A REVIEW OF THE (B)(6) SERVICE HISTORY, REVEALED NO ADDITIONAL ISSUES OF FALSE ELEVATED CREATININE REPORTED ON THE ALINITY C (B)(6) PRE OR POST SERVICE INTERVENTION FOR THE CURRENT TICKET. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CREATININE (ENZYMATIC) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR A 48-YEAR-OLD MALE PATIENT. SID (B)(6) INITIAL RESULT (B)(6) 2022 363 MOL/L, RERUN ON THE SAME INSTRUMENT 92.6 MOL/L. REPEATED ON TWO OTHER INSTRUMENT (B)(4) 91.8 MOL/L AND (B)(4) 90.9 MOL/L (REFERENCE RANGE 64-104 MOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238176 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male ALNTY C ENZ CREATININE, 08P01-30, 20520Y600.| ALNTY C ENZ CREATININE, 08P01-30, 20520Y600.