BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 221 6 SYSTEM

    MDR report key: 19730847 · Received July 12, 2024

    Report

    Report Number
    1823260-2024-02009
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 19, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    UDI-DI
    04015630018345
    PMA / PMN Number
    K032311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUCOSE CASSETTE LOT NUMBER USED AFTER THE 19-JUN-2024 EVENT IS 4149. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE PO2 ELECTRODE LOT NUMBER IS 207887/30748. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND DETERMINED REFERENCE CONTACT IN THE METABOLITE-SENSITIVE SENSOR (MSS) NEEDED TO BE REPLACED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE ANALYZER'S LOG FILES (B)(6) 2024): 117 OUT OF 118 PO2 CALIBRATIONS WERE WITHIN SPECIFICATIONS. 573 OUT OF 610 GLUCOSE CALIBRATIONS WERE WITHIN SPECIFICATIONS. THE PO2 QC WAS OUT OF RANGE (2X ON (B)(6) 2024) BUT THE RERUN WAS ACCEPTABLE. THE GLUCOSE QC WAS ACCEPTABLE. THERE WERE NO SYSTEM ERRORS NOTED. THE LOG FILES FOR PATIENT SAMPLE 3'S INITIAL RESULT SHOWED A DECLINING SAMPLE CURVE, WHILE THE REPEAT RESULT HAD NONE. THIS IS CONSISTENT WITH A PRE-ANALYTIC ISSUE (UNDETECTED INTERFERENCE OR AIR BUBBLES IN THE MEASURING CHAMBER). PRE-ANALYTICS ARE THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION REVIEWED THE RESULTS OF PATIENT SAMPLES 1 AND 2; IT WAS NOTED THAT THE PO2 AND GLUCOSE RESULTS INCREASED, WHILE THE PCO2 RESULTS DECREASED BETWEEN THE MEASUREMENTS. THE RESULTS ARE CONSISTENT WITH METABOLIZATION DUE TO IMPROPER STORAGE. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE PO2 AND GLUCOSE RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS B 221 6 ROCHE OMNI S6 SYSTEM. ON (B)(6) 2024: PATIENT SAMPLE 1 AT 6:27 AM, THE INITIAL PO2 RESULT WAS 96.3 MMHG. AT 6:30 AM, THE REPEAT RESULT WAS 124.0 MMHG. AT 6:27 AM, THE INITIAL GLUCOSE RESULT WAS 25.0 MG/DL. AT 6:30 AM, THE REPEAT RESULT WAS 148.0 MG/DL. PATIENT SAMPLE 2 AT 6:35 AM, THE INITIAL PO2 RESULT WAS 99.2 MMHG. AT 6:38 AM, THE REPEAT RESULT WAS 112.1 MMHG. AT 6:35 AM, THE INITIAL GLUCOSE RESULT WAS 17.5 MG/DL (18 MG/DL). AT 6:38 AM, THE REPEAT RESULT WAS 129.0 MG/DL. ON (B)(6) 2024: PATIENT SAMPLE 3 AT 6:13 AM, THE INITIAL GLUCOSE RESULT WAS 44.4 MG/DL. AT 6:19 AM, THE REPEAT RESULT WAS 117.7 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232836 COBAS B 221 6 SYSTEM BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS 04015630018345

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male PLEASE REFER TO THE ATTACHMENT PT-0069836.