BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CREATININE CARTRIDGE

    MDR report key: 18038122 · Received October 31, 2023

    Report

    Report Number
    2245578-2023-00149
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 24, 2023
    Report Date
    November 14, 2023
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    CGL
    PMA / PMN Number
    K973292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09-NOV-2023. AN MDR WAS FILED ON 31-OCT-2023 BASED ON THE DATA AVAILABLE AT THE TIME. ON 06-NOV-2023, THE CUSTOMER EMAILED WITH THE PATIENT'S MEDICATION LIST WHICH INCLUDED HYDROXYUREA (LISTED AS HYDREA OR HYDROXYCARBAMIDE). THE INVESTIGATION FOR THIS INCIDENT WAS OPENED ON 06-NOV-2023. AS PER ARTWORK 765791-00 REV. B REV. DATE 06-MAR-2020, I-STAT CREA CARTRIDGE, HYDROXYUREA IS A KNOWN INTERFERENT WHERE THE I-STAT CREATININE RESULTS WILL BE INCREASED. THE RECOMMENDATION IS TO USE ANOTHER METHOD. H06: TYPE OF INVESTIGATION: NO TESTING PERFORMED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD RESULTS SAMPLE I-STAT 273 MOL/L BE IV CITRATHEPARIN. I-STAT 265 MOL/L BE CAPILLARY WITHOUT ADDITIVES. LAB HELIOS 118 MOL/L MEASUREMENT FROM PLASMA (HEPARIN). LAB HELIOS 116 MOL/L REPEAT MEASUREMENT FROM THE SAME BE (PLASMA WAS FROZEN, FOR POSSIBLE FOLLOW-UP MEASUREMENTS). CUSTOMER DID NOT PROVIDE TEST/COLLECTION TIMES, DATES, NOR DETAILS SURROUND THE EVENT. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. TWO I-STAT RESULTS ARE CONSISTENTLY HIGH ON TWO DIFFERENT SAMPLES. IT IS SUSPECTED BASED ON THE ELEVATED I-STAT RESULTS THAT THE PATIENT MAY BE ON HYDROXYUREA AND THE CAUSE FOR THE ELEVATED RESULTS. HOWEVER, THERE WAS NO CONFIRMATION OF THE PATIENT'S MEDICATIONS AT THE TIME OF THIS REPORT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942361 I-STAT CREATININE CARTRIDGE CREA CARTRIDGE CGL ABBOTT POINT OF CARE INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown