BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2970285 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01087
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON ION SELECTIVE ELECTRODE- SODIUM (NA) FOR TWO PATIENT SAMPLES. THE ISSUE BEGAN ON (B)(6) 2013. OF THE TWO QUESTIONABLE SAMPLES, THE PATIENT RUN ON (B)(6) 2013, WAS DISCREPANT. ALL RESULTS ARE IN MMOL/L. THE PATIENT HAD AN INITIAL NA RESULT OF 151, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN REPEATED ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 141. THE SAMPLE WAS THEN REPEATED TWICE ON AN INTEGRA 400 SERIAL NUMBER (B)(4). THE FIRST INTEGRA RESULT WAS 136 AND THE SECOND INTEGRA RESULT WAS 136. THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. THE LOT OF NA ELECTRODE IN USE WAS T46, WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE RINSE MECHANISM TUBING WAS LOOSE AND DRIPPING. HE REATTACHED THE TUBING AND CHECKED FOR LEAKS AND PIN HOLES. HE ALSO CHECKED THE FLUIDICS AND RINSE MECHANISM. HE PERFORMED A PRECISION CHECK, CALIBRATION AND QC. THE CALIBRATION AND QC WAS ACCEPTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73556 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1