BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2211716 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04356
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS NO RAW DATA AND NO SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION. IT CAN ONLY BE SPECULATED THAT THE PROBLEM WAS CAUSED BY A SAMPLE SPECIFIC OR PIPETTING ISSUE AS CALIBRATION AND QUALITY CONTROL DATA DID NOT EXHIBIT A PROBLEM WITH THE DEVICE. THE CUSTOMER CONFIRMED NO ADVERSE EVENTS OCCURRED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE PHENYTOIN RESULTS FOR ONE PATIENT SAMPLE. THE ORIGINAL RESULT WAS 22 UG/ML WITH A DATA FLAG. THE REPEAT RESULTS WERE 13.8 AND 13.7 UG/ML. ALL OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT TREATED AS THE PHARMACIST QUESTIONED THE ORIGINAL RESULT. THE PHENYTOIN REAGENT LOT NUMBER WAS 62946501. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. AS A PREVENTATIVE MEASURE, HE REPLACED THE ABSORBANCE LAMP AND PERFORMED AN AIR/WATER CALIBRATION WHICH PASSED. HE CHECKED THE ABSORBANCE SENSITIVITY, ABSORBANCE PHOTOMETER OPTICS AND ACCURACY, WORKSTATION ACCURACY AND PROBE THROUGHPUT ALL WITH PASSING RESULTS. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH RESULTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1