BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 12964281 · Received December 8, 2021

    Report

    Report Number
    3002809144-2021-00691
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 8, 2021
    Manufacturer
    ABBOTT GMBH
    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

    THE CUSTOMER RESOLVED THE ISSUE BY REPLACING THE ICT MODULE. NO ADDITIONAL DISCREPANT PATIENT RESULT ISSUES HAVE BEEN REPORTED SINCE THE MODULE WAS REPLACED. LIST NUMBER 09D28-04 ICT MODULE/LOT 210629 WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. A REVIEW OF THE ANALYZER SERVICE HISTORY REVEALED NO SIMILAR SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF DEVICE HISTORY RECORDS AND TRENDING DATA FOR THE ICT MODULE IDENTIFIED NO TRENDS, NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO TRENDS RELATED TO THE RESULT ISSUE DESCRIBED IN THIS COMPLAINT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY DEPRESSED SODIUM RESULT WHILE USING THE ALINITY C PROCESSING MODULE. THE CUSTOMER'S NORMAL RANGE IS 134 TO 145 MMOL/L. ON (B)(6) 2021 PATIENT SAMPLE 2 GENERATED 119, 135 AND 135 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859279 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ICT MODLE, 09D28-04, (B)(4)