BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 221 <6> SYSTEM

    MDR report key: 24728310 · Received March 30, 2026

    Report

    Report Number
    1823260-2026-01157
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    UDI-DI
    04015630018345
    PMA / PMN Number
    K032311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING. MEDWATCH FIELD D2B PROCODE: PRODUCT CODE CHL APPLIES TO THE PCO2, PO2, AND PH PARAMETERS. OTHER PRODUCT CODES ASSOCIATED WITH THE COBAS B 221 <6> SYSTEM ARE CEM, CDS, CGA, GGF, GGZ, GHS, GKR, JFP, JGS, KHG, AND KHP.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT PO2, PCO2, CHCO3, BE, AND PH RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS B 221 <6> SYSTEM. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON (B)(6) 2026, RESULTING IN THE FOLLOWING VALUES: PO2 = 159.3 MMHG WITH A DATA FLAG FOR THE FIRST VALUE AND 99.8 MMHG FOR THE REPEAT VALUE PCO2 = 16.1 MMHG WITH A DATA FLAG FOR THE FIRST VALUE AND 30.2 MMHG WITH A DATA FLAG FOR THE REPEAT VALUE. CHCO3 = 12.9 MMOL/L FOR THE FIRST VALUE AND 20.6 MMOL/L FOR THE REPEAT VALUE . BE = - 6.6 MMOL/L FOR THE FIRST VALUE AND - 2.1 MMOL/L FOR THE REPEAT VALUE. PH = 7.522 WITH A DATA FLAG FOR THE FIRST VALUE AND 7.452 WITH A DATA FLAG FOR THE REPEAT VALUE. TESTING FOR THE SAMPLE WAS REPEATED ON (B)(6) 2026 WITH A SHORTER DELAY BETWEEN FIRST AND REPEAT MEASUREMENTS. THE FOLLOWING VALUES WERE OBTAINED: PO2 = 162.1 MMHG WITH A DATA FLAG FOR THE FIRST VALUE AND 156.4 MMHG WITH A DATA FLAG FOR THE REPEAT VALUE. PCO2 = 39.0 MMHG FOR THE FIRST VALUE AND 38.8 MMHG FOR THE REPEAT VALUE. CHCO3 = 19.3 MMOL/L FOR THE FIRST VALUE AND 19.0 MMOL/L FOR THE REPEAT VALUE . BE = - 6.2 MMOL/L FOR THE FIRST VALUE AND - 6.7 MMOL/L FOR THE REPEAT VALUE. PH = 7.313 WITH A DATA FLAG FOR THE FIRST VALUE AND 7.308 WITH A DATA FLAG FOR THE REPEAT VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133334 COBAS B 221 <6> SYSTEM BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS 04015630018345

    Patients

    Seq Age Sex Outcome Treatment
    1