BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1597680 · Received February 10, 2010

    Report

    Report Number
    1823260-2010-00909
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED HIGH CREATININE RESULTS FOR FIVE PATIENT SERUM SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR FOUR WERE DISCREPANT. ALL RESULTS WERE IN MG/DL. SAMPLE 1 INITIAL RESULT WAS 11.8 AND WAS REPORTED. THE PATIENT "BROUGHT THE WORK TO THE LAB STATING THE DOCTOR TOLD HIM HE WOULD BE DEAD IF THIS WAS RIGHT". THE SAMPLE WAS REPEATED (B) (6) 2010 WITH A RESULT OF 1.0. SAMPLE 2 INITIAL RESULT WAS 12.3 AND WAS REPORTED. THE REPEAT RESULT ON (B) (6) 2010 WAS 1.1. SAMPLE 3 INITIAL RESULT WAS 18.7 AND WAS NOT REPORTED. THE REPEAT RESULT ON (B) (6) 2010 WAS 1.9. SAMPLE 4 INITIAL RESULT WAS 6.3 AND WAS NOT REPORTED. THE REPEAT RESULT ON (B) (6) 2010 WAS 0.2. THE PATIENTS WERE NOT TREATED DUE TO THE HIGH RESULTS. THE USER RECALIBRATED THE ASSAY WITH QC IN RANGE AND PATIENT RESULTS "WERE FINE SINCE". THE CREATININE REAGENT LOT NUMBER WAS 61518601. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WERE DAMAGED REACTION CELLS AND REPLACED THEM. HE VERIFIED THE ANALYZER OPERATION BY RUNNING A PHOTOMETER CHECK, PRECISION CHECK AND A CELL BLANK MEASUREMENT WITH ALL RESULTS WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1