BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 221 <6> SYSTEM

    MDR report key: 22873230 · Received August 22, 2025

    Report

    Report Number
    1823260-2025-02590
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 20, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHG
    UDI-DI
    04015630018345
    PMA / PMN Number
    K032311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D2B PROCODE UPDATED.

    Additional Manufacturer Narrative · 0

    THE CARTRIDGE LOT NUMBERS AND THEIR EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HEMOGLOBIN (THB) AND HEMATOCRIT RESULTS FROM FOURTEEN (14) PATIENT SAMPLES TESTED ON THE COBAS B 221 <6> SYSTEM. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES: PATIENT SAMPLE 1 ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE ANALYZER: THE INITIAL THB RESULT WAS 5.29 G/DL. THE INITIAL HEMATOCRIT RESULT WAS 17.2%. ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE FLOW CYTOMETER: THE REPEAT THB RESULT WAS 7.7 G/DL. THE REPEAT HEMATOCRIT RESULT WAS 23.7%. PATIENT SAMPLE 2: ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE ANALYZER: THE INITIAL THB RESULT WAS 4.83 G/DL. THE INITIAL HEMATOCRIT RESULT WAS 28.3%. ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE FLOW CYTOMETER: THE REPEAT THB RESULT WAS 6.1 G/DL. THE REPEAT HEMATOCRIT RESULT WAS 17.7%. PATIENT SAMPLE 3: ON (B)(6) 2025: THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 18.6% (THE THB RESULT WAS 3.16 G/DL). THE REPEAT HEMATOCRIT RESULT FROM THE FLOW CYTOMETER WAS 10% (THE THB RESULT WAS 3.2 G/DL). PATIENT SAMPLE 4: THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 20.7% (THE THB RESULT WAS 5.14 G/DL). THE REPEAT HEMATOCRIT RESULT FROM THE FLOW CYTOMETER WAS 15.2% (THE THB RESULT WAS 4.8 G/DL). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER FOLLOWS THE GENERAL RULE THAT THE HEMATOCRIT SHOULD BE THREE TIMES THE THB RESULT, PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE FLOW CYTOMETER RESULTS WERE DEEMED BELIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666888 COBAS B 221 <6> SYSTEM BLOOD GAS ANALYZER KHG ROCHE DIAGNOSTICS 04015630018345

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female