BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3182628 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03764
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 8, 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
    VA, 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 TOTAL BILIRUBIN SPECIAL (TBIL) ON ONE PATIENT SAMPLE. ALL UNITS ARE IN MG/DL. THE CUSTOMER USED A PIPETTE TO TRANSFER THE SAMPLE FROM A MICROTAINER SPECIMEN TO A MICROCUP. THE MICROCUP WAS PLACED ON TOP OF A BARCODED 16MM TUBE AND RUN. THE INITIAL TBIL RESULT WAS 0.7, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THIS RESULT WAS QUESTIONED BY THE NURSE. THE CUSTOMER PUT THE SAME SAMPLE ON THE BARCODED TUBE ON THE OTHER COBAS 6000 C501 ANALYZER AND GENERATED A REPEAT RESULT OF 8.03. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE CORRECT AND TURNED OUT A CORRECTED REPORT. THERE WAS NO ADVERSE EVENT. THE CUSTOMER THEN MANUALLY RAN THE SAMPLE WITHOUT THE BARCODED TUBE AND GENERATED A REPEAT TBIL RESULT OF <0.01, ACCOMPANIED BY A DATA FLAG. THE SAMPLE AUTO-REPEATED AS AN INCREASED SAMPLE, AND GENERATED A RESULT OF 8.56. THE CUSTOMER WAS NOT AWARE THAT THE SAMPLE VOLUME HAD TO BE SELECTED FOR MICROCUPS WHEN THEY ARE BEING USED FOR TESTING. THE LOT OF TBIL REAGENT IN USE WAS 67525801, WITH AN EXPIRATION DATE OF 04/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE SAMPLE PROBE WAS MISALIGNED. HE ADJUSTED THE SAMPLE PROBE AND RAN SEVERAL SAMPLES IN MICROCUPS WITH NO ISSUE. HE PERFORMED INSTRUMENT TESTING AND CHECKS WHICH WERE IN ACCORDANCE WITH SPECIFICATIONS. CALIBRATION AND QC WERE WITHIN THE CUSTOMER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284074 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1