BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STAT CARTRIDGE

    MDR report key: 3995759 · Received August 8, 2014

    Report

    Report Number
    2245578-2014-00038
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 08/21/2014. RETURN AND RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE INFORMATION ASSOCIATED WITH THE CUSTOMER'S REPORTED EVENT . PRODUCT NAME/ CATALOG #/ CODE: I-STAT CARTRIDGE EG7+/ 03P76-25/ CHL; 510K: K940918; LOT#: N14050 LOT EXPIRATION: 10/14/2014 MFG DATE: 02/19/2014; N14099, 11/28/2014, 04/09/2014. PRODUCT NAME/ CATALOG # /CODE: I-STAT CARTRIDGE CHEM8+/ 03P91-25/ JGS; 510K: K053110; LOT# J14121, LOT EXPIRATION: 10/28/2014 MFG DATE: 05/01/2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT CARTRIDGES YIELDED A DISCREPANT HEMOGLOBIN RESULT ON A PATIENT GIVING BIRTH. THERE WAS NO OTHER ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. I-STAT RESULTS (G/DL): 5.1, 4.4, 4.4, 4.4, 5.4, 7.1, 5.4, 7.1, 7.5. FIRST RESULT TESTED AT 20:08, LAST RESULT TESTED AT 22:07 DURING OPERATION. COULTER LX780 RESULTS (G/DL): 9.6, 11.8, 12.7, 12.7. FIRST RESULT TESTED AT 20:30, LAST RESULT TESTED AT 23:01 DURING OPERATION. THERE WERE NO INJURIES REPORTED WITH THIS EVENT. HOWEVER, THE CUSTOMER REPORTED THE PATIENT WAS BLEEDING AND WAS GIVEN A BLOOD TRANSFUSION BASED ON THE I-STAT HEMOGLOBIN RESULTS. THE FACILITY REPORTED USING BOTH I-STAT CHEM8+ AND EG7+ CARTRIDGES DURING THE PROCEDURE. BASED ON THE INFORMATION AVAILABLE TO APOC AT THIS TIME, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469359 I-STAT CARTRIDGE SEE H10 CHL ABBOTT POINT OF CARE NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other