BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 10501985 · Received September 8, 2020

    Report

    Report Number
    3002809144-2020-00893
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 11, 2020
    Report Date
    November 13, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY COMPLAINTS THAT WERE SIMILAR FOR FALSELY ELEVATED SODIUM PATIENT RESULTS. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO TRENDS RELATED TO THIS ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: 18AUG2020 SID S549242 = 161 MMOL/L (NORMAL RANGE: 136-145 MMOL/L); ANOTHER LAB (ROCHE COBAS) = 123 MEQ/L (NORMAL RANGE: 133-146 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: ON (B)(6) 2020 SID (B)(6) = 161 MMOL/L (NORMAL RANGE: 136-145 MMOL/L); ANOTHER LAB (ROCHE COBAS) = 123 MEQ/L (NORMAL RANGE: 133-146 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NOTE: RESULTS EXPRESSED IN MEQ/L ARE EQUIVALENT TO MMOL/L FOR THIS ANALYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966462 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1