BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 3864027 · Received June 10, 2014

    Report

    Report Number
    1823260-2014-04220
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    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 THREE QUESTIONABLE HIGH RESULTS FOR CREATININE PLUS VER.2 AND BICARBONATE LIQUID. OF THE DATA PROVIDED, ONLY THE CREATININE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 24.0 MG/DL AND WAS REPORTED OUTSIDE THE LAB. THE REPEAT RESULT ON (B)(6) 2014 WAS 1.1 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER WAS 69604501 WITH AN EXPIRATION DATE OF (B)(6) 2014. THE FIELD SERVICE REPRESENTATIVE FOUND THE CUVETTE RINSE NOZZLE #3 WAS PLUGGED. HE CLEANED THE NOZZLE AND VERIFIED THE SYSTEM WAS PERFORMING TO SPECIFICATIONS. THE CUSTOMER RAN CONTROLS THAT WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341303 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR