BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 1670175 · Received April 29, 2010

    Report

    Report Number
    1823260-2010-02560
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    March 30, 2010
    Report Date
    August 19, 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

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: DATE OF ALL TESTING IS (B) (6) 2010. LOT OF MSS CASSETTE IS 21594729. PATIENT DIAGNOSIS: POST-OPERATIVE RECEIVING HIGH INTRA-VENOUS SUPPORT BOTH SAMPLES ARE FROM SAME PATIENT. ADDITIONAL RESULTS AND UNITS OF MEASURE PROVIDED (INCLUDES ALL RESULTS FOR BOTH SAMPLES): SAMPLE #1, INITIAL GLUCOSE RESULT 4.7, REPEAT ON SAME ANALYZER GAVE 7.7, REPEAT ON OMNI 9 ANALYZER GAVE 8.0, REPEAT PERFORMA GLUCOSE DEVICE GAVE 11.4 AND REPEAT ON ORIGINAL ANALYZER (OMNI S) GAVE 6.8 MMOL/L. SAMPLE #2, INITIAL GLUCOSE RESULT 4.2, REPEAT ON OMNI 9 ANALYZER GAVE 9.0, REPEAT ON PERFORMA GLUCOSE DEVICE GAVE 9.9 MMOL/L. SAMPLES WERE TESTED SIMULTANEOUSLY ON THE PERFORMA METER AND THE OMNI 9 ANALYZER, SAMPLES WERE THEN (VERY SHORTLY) TESTED ON THE OMNI S ANALYZER. THE WRONG RESULTS WERE NOT USED TO TREAT THE PATIENT. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT ALTHOUGH THE MSS SENSOR "TIME IN USE" WAS BEYOND IT'S LIMIT OF 28 DAYS, ALL QUALITY CONTROL MEASUREMENTS THAT DAY WERE WITHIN RANGE AND THE CALIBRATION SIGNALS OF THE MSS SENSOR WERE WITHIN SPECIFICATION. NO INSTRUMENT OR SENSOR RELATED PROBLEM COULD BE VERIFIED. IT WAS SUSPECTED THAT AN INTERFERING COMPOUND PRESENT IN THE SAMPLE CAUSED THE DISCREPANCIES. DUE TO INSUFFICIENT DATA, THE ROOT CAUSE COULD NOT BE IDENTIFIED. NO PATIENTS WERE ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    TECH ALLEGED BED DRIFTS DOWN FROM HIGH POSITION. HE CLEANED/DEGREASED HI/LO BRAKE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER GENERATED DISCREPANT GLUCOSE RESULTS WHEN COMPARED TO OMNI 9 BLOOD GAS ANALYZER AND PERFORMA GLUCOSE DEVICE. RESULTS FOR TWO SAMPLES WERE PROVIDED, NO UNIT OF MEASURE WERE GIVEN: SAMPLE 1, INITIAL GLUCOSE RESULT 6.8, REPEATED ON OMNI 9 ANALYZER GAVE 8.0 AND REPEATED ON PERFORMA GLUCOSE DEVICE GAVE 11.4 (PERFORMA RESULTS CONSIDERED QUESTIONABLE BY CUSTOMER). SAMPLE 2, INITIAL GLUCOSE RESULT 4.2, REPEATED ON OMNI 9 ANALYZER GAVE 9.0 AND 9.9. NO INFORMATION WAS PROVIDED TO DETERMINE IF INITIAL RESULTS WERE REPORTED. NO ADVERSE EVENTS WERE REPORTED. MSS REAGENT/BATCH LOT WAS 94729.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT THE FRONT HOUSING OF THE CALIBRATOR WAS DAMAGED. THIS CALIBRATOR WAS ORIGINALLY RETURNED FOR REPAIR OF A "CF08" ERROR WHEN THE DAMAGED FRONT HOUSING WAS FOUND. SINCE THIS EVENT OCCURRED AT THE SERVICE CENTER, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    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