BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 121

    MDR report key: 3938406 · Received July 16, 2014

    Report

    Report Number
    1823260-2014-05278
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K111188
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION ALTERNATELY TESTED SAMPLES AND QC MATERIAL TO VERIFY THAT THE COBAS B121 INSTRUMENT SENT ALL RESULTS THROUGH THE ASTM PROTOCOL TO AN ASTM SIMULATOR CORRECTLY. NO ISSUES WERE FOUND AND ALL RESULTS WERE SENT TO THE ASTM SIMULATOR CORRECTLY. BASED ON THE INVESTIGATION, IT WAS DETERMINED THE ASTM PROTOCOL WAS WORKING ACCORDING TO SPECIFICATIONS. IT WAS ASSUMED THAT THE ROOT CAUSE WAS WITH THE LIS/HIS SYSTEMS.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN ISSUE WITH THE RESULTS FOR QC MATERIAL OVERWRITING THE RESULTS FOR PATIENT SAMPLES IN THE LABORATORY INFORMATION SYSTEM (LIS). OF THE DATA PROVIDED FOR TWO PATIENT SAMPLES, THE FOLLOWING RESULTS WERE DISCREPANT. PATIENT 1: PO2 RESULT WAS 88.5 MMHG. THE LEVEL 1 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 58.6 MMHG. PCO2 RESULT WAS 35.1 MMHG. THE LEVEL 1 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 62.2 MMHG. THE LEVEL 2 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 44.6 MMHG. PH RESULT WAS 7.427. THE LEVEL 1 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 7.197. SODIUM RESULT WAS 139.7 MMOL/L. THE LEVEL 1 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 122.3 MMOL/L. CHLORIDE RESULT WAS 103.2 MMOL/L. THE LEVEL 1 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 88.4 MMOL/L. IONIZED CALCIUM RESULT WAS 4.95 MG/DL. THE LEVEL 1 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 6.09 MG/DL. THE LEVEL 2 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 4.71 MG/DL. POTASSIUM RESULT WAS 3.84 MMOL/L. THE LEVEL 2 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 4.76 MMOL/L. PATIENT 2 TESTED ON (B)(6) 2014: PO2 RESULT WAS 22.2 MMHG. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 144.0 MMHG. PCO2 RESULT WAS 57.1 MMHG. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 24.6 MMHG. PH RESULT WAS 7.243. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 7.554. SODIUM RESULT WAS 130.6 MMOL/L. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 154.4 MMOL/L. CHLORIDE RESULT WAS 99.8 MMOL/L. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 121.2 MMOL/L. IONIZED CALCIUM RESULT WAS 5.23 MG/DL. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 2.26 MG/DL. POTASSIUM RESULT WAS 3.80 MMOL/L. THE LEVEL 3 QC RESULT THAT OVERWROTE THE PATIENT RESULT WAS 7.0 MMOL/L. INFORMATION CONCERNING IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT WAS NOT PROVIDED. INFORMATION CONCERNING IF ANY PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT WAS NOT PROVIDED. INFORMATION CONCERNING THE LOT NUMBERS AND EXPIRATION DATES FOR THE ASSAYS INVOLVED WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416886 COBAS B 121 BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1