BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 18934380 · Received March 19, 2024

    Report

    Report Number
    2245578-2024-00060
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 17, 2024
    Report Date
    May 20, 2024
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4) THE INVESTIGATION WAS COMPLETED ON 15-MAY-2024. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT 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.

    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 12-MAR-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DESCREPANT RESULTS ON A 70 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 COLLECTED TESTED RESULTS(SEC) HEPARIN HEPARIN TIME (B)(6) -2024 16:08 16:08 267 2000 UNITS 16:03; (B)(6) 2024 16:23 16:23 224 1000 UNITS 16:15; (B)(6) 2024 16:34 16:34 186 4000 UNITS 16:53; (B)(6) 2024 16:46 16:47 201 NI NI; (B)(6) 2024 16:46 16:46 189 NI NI; (B)(6) 2024 NI NI NI 1653 INTEGRILIN BOLUS NI. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559950 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R23270

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female