BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 2983465 · Received February 28, 2013

    Report

    Report Number
    1823260-2013-01226
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE CLEANED THE SYSTEM WATER TANK. HE REPLACED THE WATER INLET FILTER, THE PROBE, AND THE WASH STATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE PLUS VER.2 (CREP) ON THEIR C111 ANALYZER. THE CUSTOMER PROVIDED DATA FOR THREE PATIENTS, OF WHICH TWO HAD DISCREPANT RESULTS. THE FIRST PATIENT'S INITIAL CREP RESULT WAS 199.1 UMOL/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR DECIDED TO SEND THE PATIENT TO THE EMERGENCY HOSPITAL BASED ON THE RESULT. A NEW SAMPLE WAS TESTED WITH A CREP RESULT AROUND 95 UMOL/L. ON (B)(6) 2013, THE LABORATORY REPEATED THE PATIENT'S INITIAL SAMPLE WAS REPEATED TWICE ON THE C111 ANALYZER AND THE RESULTS WERE 97.0 UMOL/L AND 99.2 UMOL/L. THE TUBE WAS SENT TO ANOTHER LABORATORY AND TESTED ON A COBAS 8000 AND THE RESULT WAS 116 UMOL/L. THE PATIENT WAS NOT HARMED BY THIS EVENT. ON (B)(6) 2013, THE SECOND PATIENT'S INITIAL CREP RESULT WAS 144.7 UMOL/L. THE SAMPLE WAS REPEATED TWICE ON THE C111 ANALYZER AND THE RESULTS WERE 83.5 UMOL/L AND 87.2 UMOL/L. THE SAMPLE WAS THEN TESTED ON A COBAS 8000 FOR VERIFICATION AND THE RESULT WAS 89 UMOL/L. IT WAS UNKNOWN IF ANY OF THE SECOND PATIENT'S RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT WAS UNKNOWN IF THE SECOND PATIENT WAS ADVERSELY AFFECTED BY THIS EVENT. THE CREP REAGENT LOT NUMBER WAS 672015 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87891 COBAS C111 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR