BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 16940054 · Received May 16, 2023

    Report

    Report Number
    3016438761-2023-00267
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 8, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INSTALLED ICT MODULE LOT # 230121 AND MULTIPLE DISCREPANT RESULTS WERE OBSERVED FOR SODIUM. THE CUSTOMER DETERMINED THE ICT MODULE WAS THE LIKELY CAUSE OF THE DISCREPANT RESULTS AND INSTALLED A NEW ICT MODULE WHICH RESOLVED THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. TRENDING REVIEW DETERMINED NO TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT SEVERAL DISCREPANT SODIUM RESULTS WERE GENERATED AFTER REPLACING THE ICT MODULE ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER WAS ABLE TO PROVIDE ONE EXAMPLE. SID NOT PROVIDED. (B)(6) 2023. INITIAL SODIUM RESULT OF 160 MMOL/L (ELEVATED) RETESTED AT 141 MMOL/L (NORMAL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT SEVERAL DISCREPANT SODIUM RESULTS WERE GENERATED AFTER REPLACING THE ICT MODULE ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER WAS ABLE TO PROVIDE ONE EXAMPLE. SID NOT PROVIDED. ON (B)(6) 2023 INITIAL SODIUM RESULT OF 160 MMOL/L (ELEVATED) RETESTED AT 141 MMOL/L (NORMAL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864516 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ICT MODLE, 09D28-04, SN (B)(6) LOT 230121| ICT MODLE, 09D28-04, SN (B)(6) LOT 230121