BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 11177174 · Received January 15, 2021

    Report

    Report Number
    3002809144-2021-00031
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 20, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE PERFORMED MULTIPLE TROUBLESHOOTING SERVICES. INCLUDING THE CLEANING OF THE CUVETTE WASHER NOZZLES, NOZZLE C4 #1, #4, #5 (ROHS) (LN 7-205228-02). WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY, REVEALED NO CONTRIBUTING FACTORS ON OR AROUND THE TIME OF THE ISSUE. THE ALINITY CI-SERIES OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. THE ALINITY C SERVICE DOCUMENTATION CONTAINS ADEQUATE INFORMATION FOR THE TROUBLESHOOTING OF THE NOZZLE C4 #1, #4, #5 (ROHS). A REVIEW FOR TRENDS FOR THE NOZZLE C4 #1, #4, #5 (ROHS) (LN 7-205228-02) DID NOT IDENTIFY ANY TRENDS FOR THE REPLACED PART. A PRODUCT MONITORING REVIEW OF THE ALINITY C TRACKING AND TRENDING DATA, REVEALED NO TREND FOR THE ALINITY C PLATFORM AND NO SIMILAR ISSUES FOR DISCREPANT RESULTS AS DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SN (B)(6), OR THE NOZZLE C4 #1, #4, #5 (ROHS) (LN 7-205228-02) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED SODIUM (NA) RESULTS ON FIVE PATIENTS GENERATED ON THE ALINITY C PROCESSING MODULE. THE RESULTS PROVIDED WERE FOR ONLY ONE PATIENT: NA = 121MMOL/L (NORMAL RANGE 136-145MMOL/L), 122, 101, 147, 127, 168, 140, 162, 137MMOL/L. THE CUSTOMER ALSO REPORTED ERRATIC (DEPRESSED/ELEVATED) CREATININE RESULTS ON FIVE PATIENTS GENERATED ON THE ALINITY C PROCESSING MODULE. THE RESULTS PROVIDED WERE FOR ONLY ONE PATIENT: CREATININE = 3.34MG/DL (RANGE 0.57-1.25MG/DL) / 0.89 AND 2.75MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75069 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1