BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17585564 · Received August 21, 2023

    Report

    Report Number
    3016438761-2023-00433
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 3, 2023
    Report Date
    September 20, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ICT MODULE AND FOUND TWO SEALS IN THE PROBE END THAT WERE CAUSING BUBBLES AND ASPIRATION ISSUES. THE FSR REMOVED THE EXTRA SEAL, FLUSHED THE MODULE AND THE ISSUE WAS RESOLVED. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE 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. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED QC OUT OF RANGE LOW FOR SODIUM AND POTASSIUM ON THE ALINITY C PROCESSING MODULE. QC WAS RERUN AND VALUES WERE WITHIN RANGE, BUT LATER FALSELY DECREASED SODIUM PATIENT RESULTS WERE OBSERVED. THE FOLLOWING DATA WAS PROVIDED. SID: (B)(6) INITIAL RESULT: 117 MMOL/L REPEAT RESULT ON OTHER INSTRUMENT: 136 MMOL/L REFERENCE RANGE: 133-147 MMOL/L CRITICAL: <120 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED QC OUT OF RANGE LOW FOR SODIUM AND POTASSIUM ON THE ALINITY C PROCESSING MODULE. QC WAS RERUN AND VALUES WERE WITHIN RANGE, BUT LATER FALSELY DECREASED SODIUM PATIENT RESULTS WERE OBSERVED. THE FOLLOWING DATA WAS PROVIDED. SID: (B)(6). INITIAL RESULT: 117 MMOL/L. REPEAT RESULT ON OTHER INSTRUMENT: 136 MMOL/L. REFERENCE RANGE: 133-147 MMOL/L. CRITICAL: <120 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726222 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown