BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 1676695 · Received May 7, 2010

    Report

    Report Number
    1823260-2010-02767
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 13, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF DATA PROVIDED INDICATED THE VENT WAS MOST LIKELY CAUSED BY A VERY SMALL AIR BUBLLE ON THE GLUCOSE PORTION OF THE MSS SENSOR. THE GLUCOSE CALIBRATION SIGNALS AT THIS TIME AS WELL AS QUALITY CONTROLS WERE CLEARLY WITHIN SPECIFICATION. THERE ARE SEVERAL POSSIBLE REASONS FOR AIR BUBBLES IN THE SYSTEM, FOR EXAMPLE, AN AIR BUBBLE HAS BEEN ASPIRATED OUT OF THE SAMPLE CONTAINER; AN AIR BUBBLE WAS GENERATED DUE TO A CLOT. AND/OR LEAKAGE IN THE FLUID PATH. FURTHER ROOT CAUSE ANALYSIS WAS LIMITED AS BOTH PARTS WERE NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED IMPLAUSIBLE RESULTS FOR ONE PATIENT SAMPLE ON THE ANALYTICAL E MODULE. THE TSH RESULT WAS <0.02 UIU/ML. THE FREE T3 RESULT WAS 15.67 NG/L. THE FREE T4 RESULT WAS 43.68 NG/L. NO ADVERSE EVENTS WERE ALLEGED REGARDING THIS EVENT. THE TSH REAGENT LOT NUMBER WAS 158157. THE FREE T3 REAGENT LOT NUMBER WAS 158371. THE FREE T4 REAGENT LOT NUMBER WAS 158155.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED INSTRUMENT SAMPLE ERRORS AND DISCREPANT GLUCOSE RESULTS FOR ONE PATIENT SAMPLE. THE SAMPLE IS FROM A BABY, BELIEVED TO BE 2 YEARS OLD. THE INITIAL RESULT FOR THIS SAMPLE WAS 1.8 MMOL/L. THIS RESULT WAS QUESTIONED AS IT CONFLICTED WITH A PREVIOUS GLUCOSE RESULT MEASURED ON A ROCHE ADVANTAGE 3 METER. THE SAMPLE TESTED ON THE METER WAS A CAPILLARY SAMPLE, HOWEVER THE DATE OF TESTING AND GLUCOSE METER RESULT WERE NOT PROVIDED. FOR CONFIRMATORY TESTING, A PLASMA SAMPLE WAS OBTAINED FROM THE BABY AND RUN ON A ROCHE MODULAR ANALYZER IN THE LABORATORY - DATE OF TESTING AND GLUCOSE RESULT NOT PROVIDED. THE ORIGINAL SAMPLE WAS THEN REPEATED ON ANOTHER ROCHE OMNI S 6 7299 BLOOD GAS ANALYZER GIVING A RESULT OF 20 MMOL/L WHICH WAS CONSIDERED THE CORRECT RESULT AS IT AGREED WITH THE GLUCOSE RESULT GENERATED FROM THE ROCHE MODULAR ANALYZER IN THE LABORATORY. INSULIN WAS WITHHELD UNTIL CONFIRMATORY TESTING WAS PERFORMED. NO ADVERSE EVENTS HAVE BEEN REPORTED IN RELATION TO THE INSULIN BEING WITHHELD. GLUCOSE REAGENT LOT NUMBER - 21500910. THE FIELD SERVICE ENGINEER DEACTIVATED AND REACTIVATED GLUCOSE TESTING ON THE ANALYZER UPON ARRIVAL AND RAN CALIBRATION AND CONTROLS WHICH WERE ACCEPTABLE. HE INSPECTED ALL MSS RELATED TUBING AND FLUID PATHWAYS AND RAN INSTRUMENT PERFORMANCE TEST WITH ALL RESULTS ACCEPTABLE. A TRIAL SAMPLE WAS RUN TO CHECK FLUIDICS WITH NO PROBLEMS FOUND. FURTHER INVESTIGATION REVEALED THERE WAS A BUBBLE IN THE SYSTEM AT THE TIME THE MEASUREMENT WAS TAKEN. THIS HAS BEEN DETERMINED TO BE A SINGLE EVENT. INSTRUMENT DATA INDICATED SEVERAL FLUIDICS ERRORS AND HANDLING ISSUES. INVESTIGATION IS ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 002 YR INSULIN| FLUIDS