BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 2871786 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06319
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 29, 2012
    Report Date
    February 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NOT ALL OF THE NECESSARY SPECIAL WASHES WERE IMPLEMENTED ON THE INSTURMENT. THE WASHES HAVE NOW BEEN CORRECTLY IMPLEMENTED.

    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 MAGNESIUM GEN 2 (MG2) ON TWO PATIENTS. OF THOSE TWO PATIENTS, ONE HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN MG/DL. PATIENT (B)(6) HAD AN ORIGINAL RESULT OF 3.68, THE SAMPLE WAS REPEATED AND GENERATED A RESULT OF 2.01. THE ORIGINAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS CONSIDERED BY THE CUSTOMER TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO ADVERSE EVENT. THE LOT OF MG 2 REAGENT WAS 65507801, WITH AN EXPIRATION DATE OF 09/30/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE INSTRUMENT MECHANICS AND THE FLUID PRESSURES WERE WITHIN SPECIFICATIONS. HE ALSO RAN AN INSTRUMENT CHECK SUCCESSFULLY. THE INSTRUMENT WAS PERFORMING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 311 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1