BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 11641264 · Received April 9, 2021

    Report

    Report Number
    3002809144-2021-00241
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ABBOTT GMBH
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6), SAMPLE ID (B)(6), AND SAMPLE ID (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSELY DEPRESSED SODIUM AND POTASSIUM RESULTS ON THE ALINITY C, SERIAL NUMBER (B)(4). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE ALINITY C-SERIES CUVETTE, LIST NUMBER 04S47-01, NEEDED TO BE REPLACED, WHICH RESOLVED THE CUSTOMER¿S COMPLAINT. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM (NA) AND POTASSIUM (K) RESULTS FOR SEVERAL PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE FOR SODIUM IS 125-149 MMOL/L; FOR POTASSIUM IS 2.6-6.4 MMOL/L): SAMPLE ID (B)(6) INITIAL NA RESULT, ON (B)(6) 2021, WAS 117, REPEAT RESULT WAS 141 MMOL/L SAMPLE ID (B)(6) INITIAL NA RESULT, ON (B)(6) 2021, WAS 113, REPEAT RESULTS WERE 138 AND 141 MMOL/L. THE SAMPLE WAS REPEATED ON THE BLOOD GAS INSTRUMENT AND THE RESULT WAS 136.9 MMOL/L. SAMPLE ID (B)(6) INITIAL K RESULT, ON (B)(6) 2021, WAS 3.3, REPEAT RESULTS WERE 2.5, 3.3, AND 3.3 MMOL/L. THE SAMPLE WAS REPEATED ON THE BLOOD GAS INSTRUMENT AND THE RESULT WAS 3.22 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539046 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1