BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1642578 · Received March 29, 2010

    Report

    Report Number
    1823260-2010-01857
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 7, 2010
    Report Date
    March 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 STATED ONE PATIENT SAMPLE "SHORT SAMPLED" ON THE ANALYZER, BUT NOT ALL OF THE RESULTS WERE FLAGGED. THE CREATININE RESULT OF 0.8 MG/DL WHICH WAS NOT FLAGGED WAS REPORTED TO THE PHYSICIAN WHO RELEASED THE PATIENT FROM THE ER. THE SAMPLE WAS AUTOREPEATED DUE TO THE FLAGS ON OTHER ASSAYS. THE REPEAT CREATININE RESULT WAS 3.0 MG/DL AND A CORRECTION WAS CALLED. THE PHYSICIAN CALLED THE PATIENT BACK TO THE HOSPITAL FOR DIALYSIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS "IN CCU". THE USER DID NOT HAVE ACCESS TO THE PATIENT'S CURRENT CONDITION. THE CREATININE REAGENT LOT NUMBER WAS 61901301. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A MISADJUSTED REAGENT PROBE 1 AND ADJUSTED IT. TO VERIFY THE ANALYZER OPERATION, THE USER RAN PRECISION TESTING, CALIBRATION AND QC WITH RESULTS WITHIN ACCEPTABLE LIMITS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR