BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1800433 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04819
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER EXPERIENCED ERRATIC CO2 RESULTS FOR MULTIPLE PATIENTS, THE EXACT NUMBER IS UNKNOWN. HE PROVIDED CO2 RESULTS FOR TWO PATIENT SAMPLES: PATIENT 1, INITIAL CO2 RESULT WAS 43.9 MMOL/L. THE SAMPLE REPEATED ON THE SAME ANALYTICAL D MODULE ((B)(4)) GAVE 28.7 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT AND WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 2, INITIAL CO2 RESULT WAS ZERO. THE SAMPLE REPEATED ON THE SAME ANALYTICAL D MODULE ((B)(4)) GAVE A NORMAL RESULT, THE EXACT VALUE WAS NOT PROVIDED. THE REPEAT RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT AFFECTED BY THE ISSUE. THE CO2 REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBES WERE MISALIGNED AND WERE HITTING THE RIGHT SIDE OF THE OUTER CUVETTES. HE CHANGED CUVETTES AND PERFORMED A PROBE ADJUSTMENT. THE FIELD SERVICE REPRESENTATIVE ALSO CLEANED THE VACUUM LINES AND VERIFIED ALL RINSE STATION ADJUSTMENTS WERE PROPERLY ALIGNED. THE USER SUCCESSFULLY RAN CO2 CALIBRATION AND QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1