BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LITHIUM

    MDR report key: 18933199 · Received March 19, 2024

    Report

    Report Number
    1823260-2024-00811
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 21, 2024
    Report Date
    March 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    UDI-DI
    07613336121382
    PMA / PMN Number
    K063684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND DID NOT FIND A CAUSE. AS THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION, A DEFINITE ROOT CAUSE ANALYSIS WAS NOT POSSIBLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE AT THE CUSTOMER SITE. THE CUSTOMER WAS USING A SHORTER CENTRIFUGATION TIME THAN WHAT IS TYPICALLY RECOMMENDED BY TUBE MANUFACTURERS. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS A2, A3, A4, B7, AND D10 WERE UPDATED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE LITHIUM RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.1 MMOL/L WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT DID NOT MATCH THE PATIENT'S HISTORY AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 2.3 MMOL/L AND WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276605 COBAS LITHIUM LITHIUM ASSAY NDW ROCHE DIAGNOSTICS ASKU 07613336121382

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female ALPRAZOLAM (XANAX)| ESTRADIOL (ESTRACE)| QUETIAPINE FUMARATE (SEROQUEL)| SYNTHROID