BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE OMNI S

    MDR report key: 7326478 · Received March 9, 2018

    Report

    Report Number
    1823260-2018-00734
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    January 31, 2018
    Report Date
    May 1, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K032311
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS USING A "CLOT CATCHER". THE "FACTORY HEPARINIZED SYRINGE" WAS A BS2 BLOOD SAMPLER.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TOTAL HEMOGLOBIN (THB) RESULT FOR ONE PATIENT WITH A COBAS B221 ANALYZER WHEN COMPARED TO A XN 1000 HEMATOLOGY INSTRUMENT. OF THE DATA PROVIDED, THERE WERE ERRONEOUS RESULTS FOR THE THB AND HEMATOCRIT (HCT) TESTS. THE THB RESULT FROM THE COBAS B 221 WAS 5.45 G/DL. THE THB RESULT USING THE SAME SAMPLE IN ANOTHER LABORATORY WITH AN XN 1000 INSTRUMENT WAS 9.60 MG/DL. THE HCT RESULT FROM THE B 221 WAS 15.0%. THE HCT RESULT USING THE SAME SAMPLE IN ANOTHER LABORATORY WITH AN XN 1000 INSTRUMENT WAS 29.50%. THE CUSTOMER STATED THEY OBSERVED THIS SAME ISSUE WITH A DIFFERENT SAMPLE ON (B)(6) 2018. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE QC RESULTS WERE CHECKED AND DETERMINED TO BE ACCEPTABLE. THE CUSTOMER STATED THAT THEY USED "FACTORY HEPARINIZED SYRINGES". THE LOT NUMBER AND EXPIRATION DATE OF THE THB CUVETTE WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171642 ROCHE OMNI S BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR