BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3182906 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03767
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 21, 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
    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 CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR SIX PATIENT SAMPLES FOR MULTIPLE ASSAYS. OF THE DATA PROVIDED FOR TWO PATIENT SAMPLES, ONLY THE VANCOMYCIN RESULT FOR ONE PATIENT SAMPLE WAS A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 31.6 UG/ML AND THE REPEAT RESULT ON ANOTHER COBAS C501 SYSTEM WAS 1.2 UG/ML WITH A DATA FLAG. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. NONE OF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO PATIENTS WERE ADVERSELY AFFECTED. THE VANCOMYCIN REAGENT LOT NUMBER WAS 67421101 WITH AN EXPIRATION DATE OF 10/31/2013. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A DAMAGED AND BENT SAMPLE PROBE. HE REPLACED THE SAMPLE PROBE AND PERFORMED SAMPLE PROBE ALIGNMENTS. HE PERFORMED MULTIPLE AIR PURGES, CLEANED RINSE MECHANISM NOZZLES AND INSPECTED THE ANALYZER FOR PROPER ELECTROMECHANICAL OPERATION DURING MECHANISM CHECKS AND OPERATION. THE CUSTOMER RAN THEIR QC MATERIAL AND ALL QC WAS WITHIN SPECIFICATIONS. A 25 CUP PRECISION TEST WAS PERFORMED AND ALL CHECKS AND TESTS WERE WITHIN DOCUMENTED GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283062 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1