BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 19296534 · Received May 13, 2024

    Report

    Report Number
    3016438761-2024-00273
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 29, 2024
    Report Date
    July 1, 2024
    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

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE MODULE AND FOUND WHITE BUILD UP AROUND THE CUVETTES. THE FSR RESOLVED THE ISSUE BY CLEANING THE CUVETTES, REPLACING THE R2 PROBE AND PERISTALTIC HEAD TUBING (ROHS). NO ADDITIONAL RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS PERFORMED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. REVIEW OF THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ALINITY SYSTEM. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SN (B)(6), WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CONTINUED INFORMATION FROM SECTION A1 PATIENT IDENTIFIER: SID (B)(6). ADDITIONAL PATIENT DETAILS ARE NOT PROVIDED. CONTINUED INFORMATION FROM SECTION E1 PHONE NUMBER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) RESULTS GENERATED ON AN ALINITY C PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: NA 133-146 MMOL/L): SID (B)(6) NA INITIAL RESULT = 170 MMOL/L, REPEAT RESULT = 140 MMOL/L. SID (B)(6) NA INITIAL RESULT = 160 MMOL/L, REPEAT RESULT = 141 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) RESULTS GENERATED ON AN ALINITY C PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: NA 133-146 MMOL/L): SID (B)(6) NA INITIAL RESULT = 170 MMOL/L, REPEAT RESULT = 140 MMOL/L, SID (B)(6) NA INITIAL RESULT = 160 MMOL/L, REPEAT RESULT = 141 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812109 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

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