BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 19166439 · Received April 23, 2024

    Report

    Report Number
    2245578-2024-00081
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 4, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 28-MAY-2024. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AN, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR EG7+ CARTRIDGE LOT N23305, CHEM8+ CARTRIDGE LOT H23287 OR EC8+ CARTRIDGE LOT K24009.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM RESULTS ON A 60 YEAR OLD MALE PATIENT WITH ABDOMINAL PAIN AND BLOOD IN URINE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECT TEST POTASSIUM SAMPLE I-STAT ON (B)(6) 2024 08:30 08:40 >9.0 A . I-STAT ON (B)(6) 2024 08:30 08:50 >9.0 A . I-STAT ON (B)(6) 2024 08:30 09:00 7.4 A . I-STAT ON (B)(6) 2024 09:10 09:15 4.4 B , GEM/3500 ON (B)(6) 2024 08:30 09:30 4.2 A . GEM/3500 ON (B)(6) 2024 09:10 09:35 3.9 B . AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189590 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K24009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male