BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 11509632 · Received March 17, 2021

    Report

    Report Number
    3002809144-2021-00175
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 18, 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
    WA, US
    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 = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED SODIUM RESULTS ON THE ALINITY C, SERIAL NUMBER (B)(4), INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. THE CUSTOMER DECLINED SERVICE DISPATCH OR TROUBLESHOOTING BY PHONE; THEREFORE, A DEFINITIVE CAUSE OF THE DISCREPANT RESULTS WAS NOT IDENTIFIED AND THE ALINITY C INSTRUMENT, SERIAL NUMBER (B)(4), WAS CONSIDERED THE LIKELY CAUSE. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR SERIAL NUMBER (B)(4) AND NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. 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 RESULTS FOR SEVERAL PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 116-146 MEQ/L): SAMPLE ID (B)(6) INITIAL RESULT WAS 115 REPEATS WERE 121, 154, AND 153 MEQ/L. SAMPLE ID (B)(6) INITIAL RESULT WAS 101, REPEAT WAS 146 MEQ/L. SAMPLE ID (B)(6) INITIAL RESULT WAS 106, REPEAT WAS 144 MEQ/L. SAMPLE ID (B)(6) INITIAL RESULT WAS 106, REPEAT WAS 148 MEQ/L. SAMPLE ID (B)(6) INITIAL RESULT WAS 108, REPEAT WAS 146 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406558 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1