BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 3994313 · Received August 8, 2014

    Report

    Report Number
    1823260-2014-06040
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF BIRTH WAS UPDATED. IT WAS LATER CONFIRMED THAT THE SAMPLE WAS INITIALLY TESTED TWICE WITH RESULTS OF 14.9 MG/L AND 20.9 MG/L. THE 14.9 MG/L AND 20.9 MG/L VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED THE FIRST TIME AT A 1:10 DILUTION ON THE ANALYZER, RESULTING AS 3410.5 MG/L.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE GEAR PUMP PRESSURE WAS TOO LOW AND THAT NO FURTHER ADJUSTMENT WAS POSSIBLE. HE REPLACED THE GEAR PUMP HEAD. IN ADDITION, HE REPLACED THE HEATCUT FILTER, SAMPLE AND REAGENT PROBES, WATER BATH SENSOR, MAINTENANCE KIT, AND VACUUM MEMBRANES AS A PREVENTIVE MEASURE. IT WAS DETERMINED THAT THE FSR ACTIONS SOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT CEREBROSPINAL FLUID SAMPLE TESTED FOR TOTAL PROTEIN IN URINE/CEREBROSPINAL FLUID (U/CSF PROTEIN). THE SAMPLE INITIALLY RESULTED AS 3410.5 MG/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 14.9 MG/L AND 20.9 MG/L. THE 14.9 MG/L AND 20.9 MG/L VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN COMPLAINED ABOUT THE REPORTED VALUES, SO THE SAMPLE WAS REPEATED MULTIPLE TIMES. THE SAMPLE WAS DILUTED 1:10 AND RESULTED AS 3313.6 MG/L. THE SAMPLE WAS REPEATED AT NORMAL SAMPLE VOLUME AND RESULTED AS 2822.5 MG/L. THE SAMPLE WAS REPEATED AT A REDUCED SAMPLE VOLUME AND RESULTED AS 3416 MG/L. THE SAMPLE WAS REPEATED AGAIN AT NORMAL SAMPLE VOLUME AND RESULTED AS 2831.6 MG/L. THE SAMPLE WAS REPEATED AGAIN AT A REDUCED SAMPLE VOLUME AND RESULTED AS 3441.4 MG/L. THE SAMPLE WAS REPEATED AT A NORMAL SAMPLE VOLUME ON ANOTHER INSTRUMENT AND RESULTED AS 2821.7 MG/L. THE SAMPLE WAS ALSO REPEATED AT A REDUCED SAMPLE VOLUME ON ANOTHER INSTRUMENT AND RESULTED AS 3460.8 MG/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE U/CSF PROTEIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467782 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR