BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2871611 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06314
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE CREATININE RESULTS WERE GENERATED AFTER A DISCREPANCY WAS NOTED IN THE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT OF 1058 UMOL/L WAS REPORTED OUTSIDE THE LABORATORY AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE NEXT DAY, A NEW SAMPLE WAS TAKEN AND THE RESULT WAS NORMAL. THE ORIGINAL SAMPLE WAS REPEATED ON A SECOND MODULAR ANALYZER AND THE RESULTS WERE 698 AND 698 UMOL/L. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULT WAS 682 UMOL/L. THE PATIENT WAS SENT HOME THE NEXT DAY WHEN THE TEST RESULTS WERE CORRECTED. IT WAS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. THE LABORATORY DECIDED TO RERUN OTHER PATIENT SAMPLES WHOSE ORIGINAL RESULTS WERE > 100 UMOL/L. OUT OF THESE 22 SAMPLES, THE RESULTS FOR FOUR SAMPLES WERE DISCREPANT. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 106 AND THE REPEAT RESULT WAS 69. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 140 AND THE REPEAT RESULT WAS 67. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 156 AND THE REPEAT RESULT WAS 76. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 117 AND THE REPEAT RESULT WAS 59. THE ORIGINAL RESULTS HAD BEEN REPORTED. IT WAS NOT KNOWN IF THE PATIENTS WERE ADVERSELY AFFECTED. THE CREATININE R1 REAGENT LOT NUMBER WAS 667024 AND THE CREATININE R2 REAGENT LOT NUMBER WAS 668653. THE EXPIRATION DATES WERE NOT PROVIDED. A FIELD SERVICE ENGINEER VISITED THE CUSTOMER AND DETERMINED TWO VACUUM TUBES FOR THE WASH STATION WERE BROKEN AND THE GEAR PUMP PRESSURE WAS TOO LOW BUT COULDN'T BE ADJUSTED. THE GEAR PUMP HEAD WAS REPLACED AND THE PRESSURE ADJUSTED. THE VACUUM MEMBRANE WAS EXCHANGE BECAUSE OF BAD VACUUM. THE CUVETTES WERE REPLACED DUE TO CONTAMINATION AFTER OVERFLOW AND THE CUVETTE FILLING WAS CHECKED AND ADJUSTED. THE INCUBATOR BATH WAS EXCHANGED AND CHECKED. THE SAMPLE PROBE WAS CHECKED AND WAS OKAY. THE SOLENOID VALVE IN THE VACUUM AND FLOW PATH WAS CHECKED AND CLEANED. THE ASSAY WAS CALIBRATED AND CONTROLS WERE RUN. PRECISION TESTING WAS OKAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1