BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 19664600 · Received July 3, 2024

    Report

    Report Number
    2245578-2024-00126
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 24, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 19-SEP-2024. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS PASSED RELEASE SPECIFICATIONS. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DESCREPANT RESULTS ON A 73 YEAR OLD FEMALE PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE TIME RESULTS (SEC) HEPARIN DOSE HEPARIN TIME (B)(6) 2024 2000 13:17 (B)(6) 2024 8000 13:22 (B)(6) 2024 13:33 259 (B)(6) 2024 2000 13:38 (B)(6) 2024 13:46 *253 (B)(6) 2024 1000 13:56 (B)(6) 2024 13:59 *253 (B)(6) 2024 3000 14:04 (B)(6) 2024 14:14 307 (B)(6) 2024 14:15 270 (B)(6) 2024 3000 14:20 AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPOPRTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDERGOING MEDICAL PROCEDURES SUCH AS CATHETERIZATION, CARDIAC SURGERY, SURGERY, ORGAN TRANSPLANT, AND DIALYSIS.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579598 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R24128

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male