BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 22010693 · Received May 13, 2025

    Report

    Report Number
    2245578-2025-00048
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 21, 2025
    Report Date
    June 3, 2025
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 02-JUN-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED 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 CHEM8+ CARTRIDGE LOT H25028.

    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

    NA.

    Description of Event or Problem · 0

    ON 22-APR-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT HEMATOCRIT RESULT ON A PATIENT. THERE WAS NO INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: HCT %PCV HGB G/DL: SAMPLE I-STAT (B)(6) 2025 14:55; 37; 12.6. I-STAT (B)(6) 2025 15:03; 23; 7.8. I-STAT (B)(6) 2025 16:44; 24; 8.2. I-STAT (B)(6) 2025 17:46; 25; 8.5. I-STAT (B)(6) 2025 19:15; 23; 7.8. I-STAT (B)(6) 2025 19:34; <15; <>. I-STAT (B)(6) 2025 19:42; 29; 9.9. I-STAT (B)(6) 2025 19:54; 16; 5.4. I-STAT (B)(6) 2025 20:59; 22; 7.5. I-STAT (B)(6) 2025 22:26; 21; 7.1. I-STAT (B)(6) 2025 23:52; 22; 7.5. 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
    1181684 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H25028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown