BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 1599499 · Received February 16, 2010

    Report

    Report Number
    1823260-2010-01028
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    January 24, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED A COMBINATION OF A LOW CALIBRATION SIGNAL AND THE CORRECTION DUE TO THE INTERFERENCE SIGNAL CAUSED THE MEASUREMENT DEVIATION IN THIS CASE. THERE WAS NO DETAILED PATIENT INFORMATION AVAILABLE (EXCEPT A MEDICATION LIST), THEREFORE THE MEDICAL STATUS OF THE PATIENTS COULD NOT BE DETERMINED. IT WAS UNKNOWN WHETHER ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER GENERATED HIGHLY VARIABLE GLUCOSE RESULTS WHEN COMPARED TO A SECOND COBAS 221 OMNI 6 AND A BAYER CONTOUR GLUCOSE METER. GLUCOSE RESULTS FOR FOUR PATIENT SAMPLES WERE PROVIDED: PATIENT 1, INITIAL RESULT 74 (THIS ANALYZER), REPEATED TWICE GAVE 120 (SECOND OMNI 6 ANALYZER) AND 107 MG/DL (BAYER METER). PATIENT 2, INITIAL RESULT 81 (THIS ANALYZER), REPEATED TWICE GAVE 110 (SECOND OMNI 6 ANALYZER) AND 82 MG/DL(BAYER METER). PATIENT 3, INITIAL RESULT 74 (THIS ANALYZER), REPEATED TWICE GAVE 115 (SECOND OMNI 6 ANALYZER) AND 111 MG/DL (BAYER METER). ALL MEDICATIONS LISTED ARE FOR THIS PATIENT. PATIENT 4, INITIAL RESULT 29 (THIS ANALYZER), REPEATED ONCE GAVE 68 MG/DL (BAYER METER). INITIAL RESULTS DID NOT MATCH CLINICAL PICTURE OF THE PATIENTS. THERE WAS NO INFORMATION FROM THE CUSTOMER THAT A PATIENT WAS AFFECTED BECAUSE OF THE ERRONEOUS RESULTS. SAMPLE TYPES AT ACCOUNT ARE ARTERIAL BLOOD AND NEONATAL BLOOD USING SAMPLE CONTAINERS ROCHE BS2 BLOOD SAMPLERS AND ROCHE CAPILLARY TUBES. THE GLUCOSE/LACTATE SENSOR WAS CHANGED, THE RESULTS WERE THEN COMPARABLE TO LABORATORY RESULTS. THE SENSOR LOT ON THIS ANALYZER WAS 21594528, SENSOR LOT ON SECOND COBAS 221 OMNI 6 WAS 21595023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE NOT FORMING PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    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