BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3921898 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05017
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MULTIPLE ASSAYS FOR TWO OF THREE SAMPLES FROM ONE PATIENT IN THE ER. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE OF THE SAMPLES WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. FOR SAMPLE 1, THE ALKALINE PHOSPHATASE GEN.2 (ALP) RESULT WAS 543 U/L, THE ASPARTATE AMINOTRANSFERASE (AST) RESULT WAS 156 U/L AND THE ALANINE AMINOTRANSFERASE (ALT) RESULT WAS 302 U/L. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE DOCTOR DID NOT ACT ON THESE RESULTS AND ORDERED THE PATIENT TO BE REDRAWN. FOR SAMPLE 2, THE ALP RESULT WAS 80 U/L, THE AST RESULT WAS 19 U/L AND THE ALT RESULT WAS 37 U/L. THE DOCTOR FELT THESE RESULTS WERE CORRECT. AN ALIQUOT OF SAMPLE 1 WAS REPEATED ON (B)(6) 2014. THE ALP RESULT WAS 172 U/L, THE AST RESULT WAS 47 U/L AND THE ALT RESULT WAS 83 U/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ALP REAGENT LOT NUMBER WAS 69559901 WITH AN EXPIRATION DATE OF 11/30/2014. THE AST REAGENT LOT NUMBER WAS 69642701 WITH AN EXPIRATION DATE OF 06/30/2015. THE ALT REAGENT LOT NUMBER WAS 69496101 WITH AN EXPIRATION DATE OF 04/30/2015. THE FIELD SERVICE REPRESENTATIVE FOUND THE GEAR PUMP PRESSURE WAS LOW AND THERE WAS AN ISSUE WITH THE SAMPLE INTEGRITY. HE ADJUSTED AND VERIFIED THE GEAR PUMP PRESSURE TO SPECIFICATION AND PERFORMED MECHANISM CHECKS. HE RAN PRECISION TESTING WITH EXCELLENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401268 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1