BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 19861955 · Received July 30, 2024

    Report

    Report Number
    2245578-2024-00157
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 25, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 01-OCT-2024. THE CUSTOMER REPORTED UNEXPECTED POTASSIUM (K) RESULT WHEN TESTING A PATIENT SAMPLE USING CHEM8+ CARTRIDGE LOT H24155. ON BOTH 28-AUG-2024 AND 30-SEP-2024, THE BUSINESS PARTNER STATED THAT THE CUSTOMER HAD BEEN USING THE INCORRECT COLLECTION TUBE FOR TESTING, AS PER CARTRIDGE AND TEST INFORMATION (CTI) ART: 714258-01Q, REV. DATE: 18-OCT-2021. THE COLLECTION OPTION FOR CHEM8+ CARTRIDGES PER ART: 714258-01Q, REV. DATE: 18-OCT-2021 IS EVACUATED TUBES WITH LITHIUM HEPARIN. SINCE THE CUSTOMER HAS RECEIVED THE PROPER GUIDANCE, THE RESULTS HAVE IMPROVED. GIVEN THAT THE USE OF AN INCORRECT TUBE WAS RESPONSIBLE FOR THE UNEXPECTED RESULTS, THE CARTRIDGE LOT DOES NOT REQUIRE FURTHER INVESTIGATION. IT IS RECOMMENDED THAT INCIDENT (B)(4) BE CLOSED TO A LEVEL 1 INVESTIGATION USING F1001 - PRODUCT FUNCTIONING ACCORDING TO SPECIFICATION AND DIRECTION.

    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 25-JUL-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT ON A PATIENT.. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD RESULTS SAMPLE: I-STAT >9.0 9 MMOL/L A; LAB 5 MMOL/L NI; LAB 5MMOL/L NI. DATES, TEST/COLLECTION TIMES NOT PROVIDED. CARTRIDGE PRODUCT LOT NOT PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200836 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown