BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 3200484 · Received July 1, 2013

    Report

    Report Number
    1823260-2013-03980
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 14, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THE CUSTOMER DID NOT PROCESS THE SAMPLE TUBE PER THE MANUFACTURER'S INSTRUCTIONS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED FOR FURTHER INVESTIGATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED FOR CREATININE JAFFE GEN.2 (CREA). THE INITIAL CREA WAS 1.78 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN COMPLAINED ABOUT THE RESULT, SO THE LABORATORY REPEATED THE TEST TWICE WITH RESULTS OF 1.01 AND 1.03 MG/DL. THE CUSTOMER ALSO TESTED ANOTHER SAMPLE COLLECTED AT THE SAME TIME WITH RESULTS OF 0.93 AND 1.03 MG/DL. BOTH 0.93 AND 1.03 MG/DL WERE THEN REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN. THE LOT NUMBER OF THE CREA REAGENT WAS 675264; THE EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE VISITED THE CUSTOMER ON 06/14/2013. HE FOUND THE DAILY MAINTENANCE HAD NOT BEEN PERFORMED, SO HE PERFORMED IT THREE TIMES. HE ALSO PERFORMED A COMPARISON BETWEEN THE C311 ANALYZER AND A C501 ANALYZER AND FOUND THE C311 ACCEPTABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299268 COBAS 311 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR