BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2063309 · Received April 19, 2011

    Report

    Report Number
    1823260-2011-02105
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HIGH PHOSPHORUS RESULTS FOR SIX PATIENT SAMPLES, OF WHICH THE RESULTS FOR FIVE WERE REPORTED OUTSIDE THE LABORATORY. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 8.1 AND THE REPEAT RESULT ON (B)(6) 2011 WAS 4.5. PATIENT SAMPLE 2 WAS FROM A FEMALE PATIENT BORN ON (B)(6). THE INITIAL RESULT ON (B)(6) 2011 WAS 11.1 AND THE REPEAT RESULT ON (B)(6) 2011 WAS 4.3. PATIENT SAMPLE 3 WAS FROM A MALE PATIENT BORN ON (B)(6). THE INITIAL RESULT ON (B)(6) 2011 WAS 10.4 AND THE REPEAT RESULT ON (B)(6) 2011 WAS 3.6. PATIENT SAMPLE 4 WAS FROM A FEMALE PATIENT BORN ON (B)(6). THE INITIAL RESULT ON (B)(6) 2011 WAS 10.6 AND THE REPEAT RESULT ON (B)(6) 2011 WAS 4.7. PATIENT SAMPLE 5 WAS FROM A MALE PATIENT BORN ON (B)(6). THE INITIAL RESULT ON (B)(6) 2011 WAS 16.3 AND THE REPEAT RESULT ON (B)(6) 2011 WAS 3.7. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE PHOSPHORUS REAGENT LOT NUMBER WAS 62701801. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC FAILURE AND CARRYOVER FROM THE REAGENTS AND REACTION CELLS. HE FOUND AND REPLACED DEFECTIVE TUBING ON THE WASTE, REPLACED THE VACUUM PUMP DIAPHRAGM AND ADDED PROBE WASHES FOR THE R1 AND R2 PROBES. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL WITH RESULTS WITHIN THE RANGES. THE FIELD SERVICE REPRESENTATIVE PERFORMED PRECISION TESTING WITH RESULTS WITHIN THE GUIDELINES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR