BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CG8 + CARTRIDGE

    MDR report key: 821987 · Received February 16, 2007

    Report

    Report Number
    2245578-2007-00007
    Event Type
    Other
    Date Received
    February 16, 2007
    Date of Event
    January 24, 2007
    Report Date
    February 16, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT SAMPLE HANDLING IS THE CAUSE OF THE DISCREPANT RESULTS. I-STAT SYSTEM MANUAL CHAPTER 10 - SAMPLE COLLECTION (ART. 714372-00F) INSTRUCTS END USERS TO REMIX BLOOD COLLECTION TUBES OR SYRINGES IF TESTING DOES NOT OCCUR IMMEDIATELY AFTER DRAWING SAMPLE. HEMATOCRIT CARTRIDGE AND TEST INFO SHEET (ART. 714178-00G) WARNS THAT ERRONEOUS HEMATOCRIT RESULTS CAN BE OBTAINED BY IMPROPER SAMPLE HANDLING. IT IS FURTHER STATED THAT THE BEST WAY TO AVOID THE EFFECT OF RED BLOOD CELLS SETTLING IN THE COLLECTION DEVICE IS TO TEST THE SAMPLE IMMEDIATELY. IF THERE IS A DELAY IN TESTING OF A MIN OR MORE, THE SAMPLE MUST BE REMIXED THOROUGHLY. ADD'L TRAINING MATERIALS HAVE BEEN SENT TO THE FACILITY TO AID IN TRAINING END USERS.

    Description of Event or Problem · 1

    ON 1/29/07, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT DURING A SURGICAL PROCEDURE FIVE DAYS EARLIER AT 12:05, A PT SAMPLE GENERATED A HEMATOCRIT RESULT OF 23 %PCV ON I-STAT CG8+ CARTRIDGE. A SAMPLE DRAWN AT THE SAME TIME WAS TESTED ON A DIFFERENT BLOOD GAS ANALYZER AND A HEMATOCRIT RESULT OF 31.3% PCV WAS GENERATED. THE PHYSICIAN STATED THAT THIS PT WAS TRANSFUSED UNNECESSARILY BASED UPON THE I-STAT RESULT OF 23% PCV. CUSTOMER STATES THAT END USERS DO NOT ALWAYS MIX THE SAMPLES PRIOR TO ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CG8 + CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA L06272

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other