BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 15214963 · Received August 11, 2022

    Report

    Report Number
    3016438761-2022-00362
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 21, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: SID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND OBSERVED CRACKED INSULATION ON THE ICT CABLE. THE FSR REPLACED THE REPLACED THE ICT MODULE AND THE ICT CABLE WHICH RESOLVED THE ISSUE. THE ICT MODULE AND THE ICT CABLE WERE DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL DISCREPANT RESULTS REPORTED FOR AC02857. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ALINITY C SYSTEM, LIKELY CAUSE PARTS, OR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE FOR SERIAL NUMBER (B)(6) OR THE LIKELY CAUSE PARTS WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR SEVERAL PATIENTS. THE RESULTS DID NOT MATCH THE PATIENT¿S HISTORICAL RESULTS. THE FOLLOWING DATA WAS PROVIDED (LAB¿S REFERENCE RANGE IS 132-146 MMOL/L): SID (B)(6) INITIAL RESULT = 116 MMOL/L. SID (B)(6) INITIAL RESULT = 114 MMOL/L. SAMPLES WERE REPEATED ON DIFFERENT ANALYZERS AND THE RESULTS WERE STILL CRITICAL (NO DATA PROVIDED ON THE REPEAT). THE PHYSICIAN SENT THE PATIENTS TO A DIFFERENT LAB AND NEW SAMPLES WERE DRAWN WHICH GENERATED NORMAL SODIUM RESULTS (NO DATA PROVIDED BUT RESULTS WERE WITHIN THE NORMAL RANGE OF 132-146 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303506 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C ICT SAMPLE DILU,07P53-20,UNKNOWN| ALNTY C ICT SAMPLE DILU,07P53-20,UNKNOWN