BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 21160283 · Received January 15, 2025

    Report

    Report Number
    2245578-2025-00004
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 7, 2024
    Report Date
    February 26, 2025
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 20-FEB-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CHEM8+ CARTRIDGE LOT H24291A.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT CREATININE RESULTS ON A FEMALE PATIENT. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. METHOD : DATE : COLLECTED TESTED: RESULTS : SAMPLE: I-STAT, ON (B)(6)2024, 11:19 , 11:20 , 2.1 MG/DL, A: WB. LAB , ON (B)(6) 2024, 11:19 NI , 0.71 , A: SERUM. I-STAT ,ON (B)(6) 2024 , 10:48 10:48 , 2.1 MG/DL, B: WB. LAB , ON (B)(6)2024, 10:48 NI , 0.75 , B: SERUM. 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
    1584187 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female