BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21143388 · Received January 13, 2025

    Report

    Report Number
    3016438761-2025-00023
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. A1 - PATIENT IDENTIFIER: (B)(6) (2 DIFFERENT PATIENTS) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE, SERIAL (B)(6) WHILE USING ALINITY C ICT SAMPLE DILUENT REAGENT LOT 18603UN24 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AS PART OF TROUBLESHOOTING, THE CUSTOMER RETESTED THE SAMPLES USING THE SAME LOT AND GENERATED LOWER RESULTS. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY C PROCESSING MODULE ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE ICT SAMPLE DILUENT LOT 18603UN24. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) OR THE ALINITY C ICT SAMPLE DILUENT LOT 18603UN24 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM RESULTS FOR MULTIPLE SAMPLES GENERATED ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6)2025: SAMPLE ID (B)(6) INITIAL SODIUM RESULT ON MODULE 3 (B)(6) = 179 MMOL/L. REPEATED SODIUM ON GEM PREMIER (BLOOD GAS ANALYZER) = 141 MMOL/L. REPEATED ON MODULE 1 (B)(6) = 141 MMOL/L. REPEATED ON MODULE 3 (B)(6) = 159 / 152 / 152 / 143 / 142 / 147 MMOL/L. ON (B)(6)2025 REPEATED TESTING AFTER RE-CALIBRATION ON MODULE 3 (B)(6) = 138 / 139 / 139 / 139 / 140 MMOL/L. SAMPLE ID (B)(6): INITIAL SODIUM RESULT ON MODULE 3 (B)(6) = 172 MMOL/L. REPEAT SODIUM RESULT ON MODULE 1 (B)(6) = 141 MMOL/L. THE CUSTOMER 'S REFERENCE RANGE FOR SODIUM IS 136 TO 145 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM RESULTS FOR MULTIPLE SAMPLES GENERATED ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025: SAMPLE ID (B)(6). INITIAL SODIUM RESULT ON MODULE 3 (B)(6) = 179 MMOL/L. REPEATED SODIUM ON GEM PREMIER (BLOOD GAS ANALYZER) = 141 MMOL/L. REPEATED ON MODULE 1 (B)(6) = 141 MMOL/L. REPEATED ON MODULE 3 (B)(6) = 159 / 152 / 152 / 143 / 142 / 147 MMOL/L. ON (B)(6) 2025 REPEATED TESTING AFTER RE-CALIBRATION ON MODULE 3 (B)(6) = 138 / 139 / 139 / 139 / 140 MMOL/L. SAMPLE ID (B)(6): INITIAL SODIUM RESULT ON MODULE 3 (B)(6) = 172 MMOL/L. REPEAT SODIUM RESULT ON MODULE 1 (B)(6) = 141 MMOL/L. THE CUSTOMER 'S REFERENCE RANGE FOR SODIUM IS 136 TO 145 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178544 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, 18603UN24