BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 21514289 · Received March 4, 2025

    Report

    Report Number
    2245578-2025-00028
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 21, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 25-MAR-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 H24341.

    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

    (B)(4). REFER TO SECTIONS BELOW FOR UPDATES: B5 - COMMUNCATION FROM FDA. D2B - DEVICE PRODUCT CODE: UPDATE FROM JGS TO JPI.

    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 A DISCREPANT CREATININE RESULT ON PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: CREA SAMPLE: I-STAT 300 UMOL/L , A, LAB 100 UMOL/L , B. 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.

    Description of Event or Problem · 0

    THIS CORRECTION IS BASED ON COMMUNICATION RECIEVED ON 25-MAR-2025 FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH: MDR REPORT (#2245578-2025-00028) WHICH HAS AN INCORRECT PRODUCT CODE AND 510(K) NUMBER. IN THIS REPORT YOU STATE THAT "ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PRODUCT THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A PATIENT. CURRENTLY, THE REPORT (#2245578-2025-00028) LISTS PROCODE: JGS. PRODUCT CODE JPI IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585382 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H24341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown