BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 3033341 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02022
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATION AND QUALITY CONTROL DATA WAS WITHIN THE SPECIFIED RANGE. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE CLEANED THE SYSTEM'S WATER TANK AND REPLACED THE SAMPLE PROBE. A PRECISION CHECK WAS PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE CREATININE PLUS VER.2 (CREP) RESULT FOR ONE PATIENT ON THEIR C111 ANALYZER. THE PATIENT'S INITIAL CREP RESULT WAS 2.6 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN ASKED FOR THE SAMPLE TO BE REPEATED. THE REPEAT RESULT WAS 0.6 MG/DL. THE CUSTOMER REPEATED THE SAMPLE THREE MORE TIMES AND THE RESULTS WERE 0.7 MG/DL, 0.6 MG/DL, AND 0.7 MG/DL. THERE WERE NO ADVERSE EVENTS. THE CREP REAGENT LOT NUMBER WAS 672015 AND THE EXPIRATION DATE WAS 07/30/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137192 COBAS C111 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1