BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 1692362 · Received May 18, 2010

    Report

    Report Number
    1823260-2010-02974
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    March 10, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE ANALYZER PERFORMED WITHIN SPECIFICATIONS. NO MALFUNCTION WAS OBSERVED AS THE DATABASE OF QUALITY CONTROL SHOWED ALL MEASUREMENTS PERFORMED WERE WITHIN THE ACCEPTABLE RANGES. AS THE SURVEY SAMPLES WERE NOT AVAILABLE, FURTHER INVESTIGATION WAS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED FROM A HOSPITAL REGARDING INACCURATE READINGS ON AN ADC BLOOD GLUCOSE METER IN COMPARISON TO THE LAB READINGS. IT WAS REPORTED THAT A METER READING OF HI (GREATER THAN 27.7 MMOL/L) WAS RECEIVED WITHIN 10 MINUTES OF A LAB READING OF 3.2 MMOL/L. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE USER STATED SHE FAILED PROFICIENCY TESTING FOR PH, PCO2 AND PO2 WITH THE BLOOD GAS ANALYZER. OF THE DATA PROVIDED, THE FOLLOWING RESULTS WERE DISCREPANT. PH: SAMPLE 1 RESULT WAS 7.318, ACCEPTABLE RANGE WAS 7.497-7.577. SAMPLE 2 RESULT WAS 7.290, ACCEPTABLE RANGE WAS 7.532-7.612. SAMPLE 3: RESULT WAS 7.298, ACCEPTABLE RANGE WAS 7.444-7.524. PCO2 (MMHG): SAMPLE 1 RESULT WAS 47.3, ACCEPTABLE RANGE WAS 21.4-31.4. SAMPLE 2 RESULT WAS 53.5, ACCEPTABLE RANGE WAS 35.0-45.0. SAMPLE 3 RESULT WAS 51.3, ACCEPTABLE RANGE WAS 18.9-28.9. SAMPLE 4 RESULT WAS 46.2, ACCEPTABLE RANGE WAS 26.9-36.9. PO2 (MMHG): SAMPLE 1 RESULT WAS 117.6, ACCEPTABLE RANGE WAS 146.0-158.4. SAMPLE 2 RESULT WAS 118.5, ACCEPTABLE RANGE WAS 206.8-226.6. NO PATIENT SAMPLES WERE AFFECTED. THE USER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI BLOOD GAS ANALYZER JJC ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1