BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 123 <4> SYSTEM

    MDR report key: 4243078 · Received November 11, 2014

    Report

    Report Number
    1823260-2014-08761
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    December 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K111188
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION OF PROVIDED INSTRUMENT DATA SHOWED NO ABNORMALITIES.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE GLUCOSE RESULT FOR ONE PATIENT SAMPLE COMPARED TO THE RESULT FROM A "BAYER COUNTOUR" DEVICE. THE RESULT FROM THE COBAS B123 WAS 177 MG/DL AND THE RESULT FROM THE BAYER DEVICE WAS 120 MG/DL. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED. THE GLUCOSE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. UPON FOLLOW-UP, THE CUSTOMER STATED ALL COMPARISONS WERE GOOD AND THE CAUSE WAS THOUGHT TO BE PREANALYTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727059 COBAS B 123 <4> SYSTEM BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1