BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LITHIUM

    MDR report key: 16456723 · Received February 28, 2023

    Report

    Report Number
    1823260-2023-00621
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    January 30, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    UDI-DI
    07613336121382
    PMA / PMN Number
    K063684
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION PERFORMED ON 29-JAN-2023 WAS WITHIN SPECIFICATIONS. THE QC RECOVERY WAS WITHIN -2 STANDARD DEVIATIONS (SD). THERE IS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE FIELD APPLICATIONS SPECIALIST (FAS) INSPECTED THE ANALYZER AND FOUND THAT THE ISSUE WAS DUE TO INTERFERENCE WITH THE HDL ASSAY. THE CUSTOMER WORKED WITH FAS TO CONFIGURE AN EXTRA WASH CYCLE. THEY PERFORMED OPERATIONAL TESTS AND QC WITH ACCEPTABLE RESULTS. AFTER THIS INTERVENTION, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.  PRODUCT LABELING STATES "TO AVOID CARRYOVER BETWEEN TESTS, THE SYSTEM CAN PERFORM SPECIAL WASHES . DOWNLOAD ALL REQUIRED SPECIAL WASHES ( MANUFACTURER RULES). YOU CAN PROGRAM ADDITIONAL SPECIAL WASHES MANUALLY ( USER RULES)." THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH LI LITHIUM ON A COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. DUE TO PREVIOUS ISSUES, THE SAMPLES WERE REPEATED ON A SECOND ANALYZER ON 03-FEB-2023 AND THESE VALUES WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 1.2 MMOL/L AND REPEATED AS 0.7 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 1.9 MMOL/L AND REPEATED AS 0.6 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142815 COBAS LITHIUM LITHIUM ASSAY NDW ROCHE DIAGNOSTICS NA 59094201 07613336121382

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female