BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2943227 · Received February 5, 2013

    Report

    Report Number
    1823260-2013-00667
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE FOR THE EVENT. IT WAS DETERMINED THE CARRYOVER DUE TO THE ISSUES FOUND BY THE FSR WOULD HAVE CAUSED HIGHER RESULTS, AND NOT LOWER RESULTS. THEREFORE, THESE ISSUES WERE NOT THE CAUSE OF THE EVENT. NO OTHER ANALYZER OR REAGENT ISSUE WAS SUSPECTED. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE FOUND A SMALL CUT IN THE DETERGENT DISPENSE TUBING WHICH WAS NOT ALLOWING A FULL AMOUNT OF DETERGENT TO FILL THE CUVETTE RESULTING IN CARRY-OVER. HE REPAIRED THE DETERGENT TUBING AND READJUSTED CUVETTE RINSE LEVELS. TO VERIFY THE ANALYZER OPERATION, HE SUCCESSFULLY INITIALIZED THE ANALYZER AND VERIFIED THE RINSE LEVELS. THE CUSTOMER THEN SUCCESSFULLY RAN CONTROLS AND A PATIENT PRECISION.

    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 A QUESTIONABLE MICROALBUMIN (ALBUMIN GENERATION 2) RESULT FOR ONE PATIENT URINE SAMPLE. THE INITIAL RESULT WAS 3.9 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. ON (B)(6) 2013, THE REPEAT RESULT WAS 4.2 MG/DL WITH A DATA FLAG AND 425.6 MG/DL WHEN TESTED WITH A DECREASED SAMPLE VOLUME. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ALBUMIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48964 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 096 YR