BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

    MDR report key: 6926811 · Received October 7, 2017

    Report

    Report Number
    2245578-2017-00547
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 24, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749001917
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WAS EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. CARTRIDGE INFORMATION ASSOCIATED WITH THE CUSTOMER'S REPORTED EVENT PRODUCT NAME: I-STAT CARTRIDGE EC8+/ CATALOG # 03P79-25 / PRODUCT CODE: CHL; LOT# K17099 / LOT EXPIRATION: 10/28/2017 / MFG DATE: (B)(4) 2017/ 510K: K940918.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4).THE INVESTIGATION WAS COMPLETED ON 11/23/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+, EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A PATIENT (DOG). CUSTOMER REPORTS TWO UNEXPECTED POTASSIUM RESULTS OF > 9 ON THE SAME SAMPLE. THE SAME SAMPLE WAS THEN RUN ON THE SITE'S CATALYST ANALYZER, K RESULT WAS 3.2. SITE COULD NOT RETEST AS THE ANIMAL WAS SCHEDULED TO BE EUTHANIZED, HOWEVER A SAMPLE FROM A DIFFERENT DOG WAS RUN ON BOTH CARTRIDGE TYPES AND GENERATED EXPECTED RESULTS. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE RESULT OF >9 RESULTED ON TWO DIFFERENT CARTRIDGE TYPES ON THE SAME SAMPLE. HEMOLYSIS IS SUSPECTED BUT NOT CONFIRMED AT THIS TIME. APOC HAS REQUESTED ALL OTHER TESTS FROM BOTH CARTRIDGES. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706213 I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+) CHEM8+ CARTRIDGE (SEE H10 FOR EC8+) JGS ABBOTT POINT OF CARE NA H17195B 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1