BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3211172 · Received July 8, 2013

    Report

    Report Number
    1823260-2013-04089
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 8, 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 CREATININE JAFFE GEN.2 (CREAJ) ON ONE PATIENT URINE SAMPLE AND ON ONE PATIENT SERUM SAMPLE. OF THE TWO SAMPLES, IT WAS DETERMINED THAT ONLY THE URINE CREAJ SAMPLE HAD ERRONEOUS RESULTS THAT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN MG/DL. THE INITIAL RESULT FOR CREAJ WAS <4.2, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY A PHYSICIAN AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 64. THIS RESULT WAS DEEMED TO BE THE CORRECT RESULT. THE CUSTOMER DID NOT KNOW IF THE PATIENT WAS ADVERSELY AFFECTED. THE LOT OF CREAJ REAGENT IN USE WAS 67526401, WITH AN EXPIRATION DATE OF 10/31/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THE RINSE MECHANISM NOZZLE 1 WAS MISALIGNED. THE NOZZLE TIP WAS FLINGING WATER ONTO THE BOTTOM OF THE RINSE MECHANISM, WHICH WAS DRIPPING DOWN INTO THE CELLS. HE REALIGNED THE RINSE MECHANISM AND THE RINSE NOZZLE 1. THE CUSTOMER PERFORMED QC, WHICH PASSED. THE SYSTEM WAS OPERATING ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309710 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1