BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 19073946 · Received April 9, 2024

    Report

    Report Number
    2245578-2024-00077
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 31, 2024
    Report Date
    April 28, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    UDI-DI
    10054749005519
    PMA / PMN Number
    K183680NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 29-APR-2024. 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 FOUND IN Q04.01.003 REV. AN, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, FOR POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA) BUT FAILED THE SUPPRESSED RESULTS CRITERION. A DEFICIENCY HAS BEEN IDENTIFIED FOR THIS ISSUE WHICH WILL BE INVESTIGATED IN QUALITY RECORD (QR) 972445.

    Description of Event or Problem · 0

    ON 02-APR-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON AN 70 YEAR OLD MALE PATIENT WITH AN ACUTE KIDNEY INJURY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED CREA(MG/DL) I-STAT (B)(6) 2024 13:43 13:43 9.6 LAB (B)(6) 2024 21:10 22:20 6.7 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
    539213 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H24018A 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male