BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3222265 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04210
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR CREATITNINE PLUS VER.2 (CREAE) ON TWO PATIENT SAMPLES. ALL RESULTS ARE IN MG/DL. PATIENT 1 HAD ORIGINAL CREAE RESULT OF < 4.6 ON A URINE SAMPLE. THE ORIGINAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 64. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT AND ISSUED A CORRECTED REPORT. THERE WAS NO ADVERSE EVENT. PATIENT 2 HAD AN ORIGINAL CREAE RESULT OF < 0.2 ON A SERUM SAMPLE. THE ORIGINAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 0.9. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT AND ISSUED A CORRECTED REPORT. THERE WAS NO ADVERSE EVENT. THE CUSTOMER REFUSED TO PROVIDE THE LOT NUMBER AND EXPIRATION DATE OF THE CREAE REAGENT THAT WAS IN USE. THE FIELD SERVICE REPRESENTATIVE FOUND THAT NOZZLE 1 ON THE RINSE MECHANISM WAS MISALIGNED. THE WHITE NOZZLE TIP WAS FLINGING WATER ONTO THE BOTTOM OF THE RINSE MECHANISM, AND THEN DRIPPING DOWN INTO THE CELLS. HE REALIGNED THE RINSE MECHANISM AND RINSE NOZZLE 1. THE SYSTEM WAS OPERATING ACCORDING TO SPECIFICATIONS. WATER WAS NO LONGER ACCUMULATING ON THE BOTTOM SIDE OF THE RINSE MECHANISM. THE CUSTOMER PASSED QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322786 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1