BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 20953798 · Received December 17, 2024

    Report

    Report Number
    2245578-2024-00216
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 10, 2024
    Report Date
    March 10, 2025
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THIS CORRECTION IS TO UPDATE THE PRODUCT INFORMATION: PRODUCT: SEE D 1, 2, 4. CHANGE FROM I-STAT TO CHEM8+ PRODUCT. PMA/510(K): G4. CHANGE FROM K183680 TO K183688. 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 05-MAR-2025. THE CUSTOMERS OBSERVED UNEXPECTED SODIUM (NA), POTASSIUM (K), IONIZED CALCIUM (ICA), BUN/UREA, HEMOGLOBIN (HB), AND CREATININE (CREA) RESULTS, AS WELL AS UNEXPECTED CHLORIDE (CL) AND EGFR RESULTS WHEN TESTING PATIENT SAMPLES WITH AN UNKNOWN CHEM8+ CARTRIDGE LOT, AS COMPARED TO A LAB INSTRUMENT. SHIPPING INFORMATION WAS NOT AVAILABLE; PER THE ABBOTT PRODUCT PLANNER, A REVIEW OF SHIPPING INFORMATION DID NOT IDENTIFY ANY LOTS SHIPPED TO THIS CUSTOMER SINCE 2022. A REVIEW OF THE DEVICE HISTORY RECORD AND RETAINED AND RETURNED CARTRIDGE LOT TESTING WAS NOT APPLICABLE AS THE LOT NUMBER WAS UNKNOWN. SEARCHES OF QUALITY SYSTEM PROCESSES (QUALITY RECORDS (QR), STABILITY AND COMPLAINTS) SHOW NO INDICATION OF RELATED PERFORMANCE ISSUES IDENTIFIED WITH UNEXPECTED NA, K, ICA, BUN/UREA, HB, CREA, CL, AND EGFR RESULTS DURING THE TIMEFRAME OF THIS INCIDENT. THERE WERE NO STABILITY RELATED OOS'S INITIATED, AND NO SYSTEMIC PERFORMANCE ISSUE HAS BEEN IDENTIFIED. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT (B)(4). CUSTOMER IS USING CHEM8+, CARTRIDGE LOT IS UNKNOWN. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    SEE H11 FOR CORRECTION DETAILS.

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT SN (B)(6) THAT YIELDED A DISCREPANT POTASSIUM RESULT OF >9 ON PATIENT. THE CUSTOMER REPORTED ABNORMAL RESULTS ON I-STAT AND REQUESTS ANALYZER IS SENT FOR REPAIR. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. CARTRIDGE PRODUCT LOT INFORMATION WAS NOT PROVIDED. METHOD NA K UREA CREA ICA HB HCT, I-STAT 115 >9 18.3 149 0.57 159 NI, LAB 134 4.6 11.1 116 2.3 139 NI, TEST/COLLECTION TIMES WERE NOT REPORTED. 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
    1720124 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE, JPI ABBOTT POINT OF CARE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown