BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 19135578 · Received April 18, 2024

    Report

    Report Number
    1823260-2024-01202
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 760433. THE EXPIRATION DATE WAS NOT PROVIDED. GENERAL REAGENT ISSUES WERE EXCLUDED AS THE CORRECT RESULT WAS OBTAINED WITH THE SAME REAGENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND THE MAIN WATER PRESSURE WAS OUTSIDE OF SPECIFICATIONS. THE ANALYZER ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION ALARMS, SAMPLE SHORT ALARMS, AND SAMPLE PIPETTOR ALARMS. THESE ALARMS INDICATE AN ISSUE WITH SAMPLE QUALITY. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW CHOLESTEROL RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.23 MMOL/L. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 5.05 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424639 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male