BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 18777806 · Received February 26, 2024

    Report

    Report Number
    2245578-2024-00049
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 14, 2024
    Report Date
    April 16, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749001917
    PMA / PMN Number
    K053110NA
    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). THE INVESTIGATION WAS COMPLETED ON (B)(6) 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 SUPPRESSED RESULTS AND FOR POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA) FOR ALL ANALYTES EXCEPT TOTAL CARBON DIOXIDE (TCO2) IN WHOLE BLOOD (WB). A DEFICIENCY HAS BEEN IDENTIFIED FOR THIS ISSUE WHICH WILL BE INVESTIGATED IN QUALITY RECORD (QR) (B)(4).

    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

    ON 15-FEB-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT CREA RESULTS ON AN 82 YEAR OLD FEMALE PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED RESULT (UNITS) & SAMPLE. I-STAT, (B)(6) 2024, 1320, 1323, 360 UMOL/L & A. PICCOLO, (B)(6) 2024, 1320, 1323, 62 UMOL/L & A. I-STAT, (B)(6) 2024, 1350, 1354, 346 UMOL/L & B. PICCOL0, (B)(6) 2024, 1350, 1354, 68 UMOL/L & B. LAB, (B)(6) 2024, 1350, 1536, 74 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298553 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H23340 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female