BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17759466 · Received September 15, 2023

    Report

    Report Number
    3016438761-2023-00500
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSELY DECREASED SODIUM AND FALSELY ELEVATED POTASSIUM RESULTS ON THE ALINITY C, SERIAL NUMBER (B)(6) . THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE CABLE, ICT TO ICT PREAMPSYR, PART NUMBER C-35016756-01, NEEDED TO BE REROUTED TO ENSURE IT WAS NOT RUBBING THE BACK PLATE, WHICH RESOLVED THE CUSTOMER¿S COMPLAINT. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS REPORTED BY THE CUSTOMER SINCE THE CURRENT COMPLAINT. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. MEDICAL DEVICE PROBLEM CODE ANNEX A WAS UPDATED FROM (B)(6) TO (B)(6) .

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1: PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6) AND SAMPLE ID (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED SODIUM (NA) AND FALSELY ELEVATED POTASSIUM (K) RESULTS FOR TWO PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR NA IS 136-145 MMOL/L, FOR K IS 3.5-5.1 MMOL/L): SAMPLE ID (B)(6) , INITIAL NA RESULT, ON (B)(6) 2023, WAS 117, REPEATS WERE 138 AND 137 MMOL/L. SAMPLE ID (B)(6), INITIAL NA RESULT, ON (B)(6), WAS 118, REPEATS WERE 120 AND 140 MMOL/L; INITIAL K RESULT WAS 8.1, REPEATS WERE 5.4 AND 3.7 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED SODIUM (NA) AND FALSELY ELEVATED POTASSIUM (K) RESULTS FOR TWO PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR NA IS 136-145 MMOL/L, FOR K IS 3.5-5.1 MMOL/L): SAMPLE ID (B)(6) INITIAL NA RESULT, ON (B)(6) 2023, WAS 117, REPEATS WERE 138 AND 137 MMOL/L. SAMPLE ID (B)(6) INITIAL NA RESULT, ON (B)(6), WAS 118, REPEATS WERE 120 AND 140 MMOL/L; INITIAL K RESULT WAS 8.1, REPEATS WERE 5.4 AND 3.7 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303367 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown