BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3133607 · Received May 29, 2013

    Report

    Report Number
    1823260-2013-03221
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ETHANOL GEN 2 (ETOH) ON ONE PATIENT SAMPLE. ALL RESULTS ARE IN MG/DL. THE ORIGINAL RESULT WAS 19 MG/DL, WHICH WAS REPORTED OUT OF THE LABORATORY AS POSITIVE. THE NURSE REQUESTED REPEAT TESTING DUE TO CONCERN THE RESULT COULD NOT BE CORRECT. THE TESTING WAS REPEATED ON A SECOND SAMPLE TUBE THAT WAS DRAWN AT THE SAME TIME. THE RESULT OF THIS REPEAT TEST WAS ZERO. THE ORIGINAL SAMPLE TUBE WAS REPEATED AND GENERATED A RESULT OF 2. THE CUSTOMER'S CUT OFF IS 10, AND THE RESULT WAS REPORTED AS <10 (NEGATIVE). THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. THERE WAS NO ADVERSE EVENT. THE LOT OF ETOH REAGENT IN USE WAS 67557001, WITH AN EXPIRATION DATE OF 09/30/2013. THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THAT THERE WAS SAMPLE CARRYOVER DUE TO A CLOT WITH THE PREVIOUS SPECIMEN. THE SAMPLE WAS RERUN AND REPEATED TWICE WITH A NEGATIVE RESULT. THE FSR INDICATED THAT NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235179 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1