BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 19791688 · Received July 22, 2024

    Report

    Report Number
    1823260-2024-02089
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER IS 803015. THE UA REAGENT LOT NUMBER IS 776865. THE REAGENT EXPIRATION DATES WERE NOT PROVIDED. THE ALARM TRACE SHOWED SEVERAL "PHOTOMETRIC REAGENT BELOW WARNING LEVEL" ALARMS AND "ABNORMAL ASPIRATION" REAGENT PIPETTER ALARMS. THE FIELD SERVICE REPRESENTATIVE CHANGED THE TUBING SET, THE TRAP BOTTLE, AND A VALVE. A GENERAL REAGENT ISSUE WAS EXCLUDED. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE URIC ACID PAP (UA2) RESULTS FOR 4 PATIENT SAMPLES AND QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. PATIENT 1: THE INITIAL UA2 RESULT WAS 18.8 MG/DL WITH A DATA FLAG. THE REPEATED RESULT WAS 4.54 MG/DL. PATIENT 2 THE INITIAL UA2 RESULT WAS 22.5 MG/DL WITH A DATA FLAG. THE REPEATED RESULT WAS 9.41 MG/DL. PATIENT 3: THE INITIAL UA2 RESULT WAS 18.8 MG/DL WITH A DATA FLAG. THE REPEATED RESULT WAS 5.54 MG/DL. PATIENT 4: THE INITIAL UA2 RESULT WAS 21.4 MG/DL WITH A DATA FLAG. THE REPEATED RESULT WAS 5.05 MG/DL PATIENT 5: THE INITIAL CA RESULT WAS 1.60 MMOL/L. THE REPEATED RESULT WAS RESULT 2.39 MMOL/L. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE CONSIDERED TO BE WITHIN THE EXPECTED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736425 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown