BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 17001713 · Received May 25, 2023

    Report

    Report Number
    2245578-2023-00061
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 11, 2023
    Report Date
    July 25, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    UDI-DI
    10054749000149
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 25-JUL-2023. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT PASSED RELEASE SPECIFICATIONS. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA IN APPENDIX 1 OF Q04.01.003 REV. AK (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED QUALITY CHECK CODE 44 ON A PATIENT DURING SURGERY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. THE CUSTOMER STATES THAT ON (B)(6) 2023, QUALITY CHECK CODE 44 (QCC 44) OCCURRED MULTIPLE TIMES ON A PATIENT DURING A PROCEDURE WITH MULTIPLE ANALYZERS. OTHER CASES RUNNING THE SAME DAY WITH DIFFERENT PATIENTS AND USING THE SAME CARTRIDGE LOT FUNCTIONED AS EXPECTED. PER DOCTOR, A HEPARIN BOLUS AND DRIP WERE STARTED, WITH SERIAL MONITORING OF ACTS TO KEEP ACT BETWEEN 350-400 SECONDS. QCC 44 OCCURRED AND UNABLE TO OBTAIN AN I-STAT ACT RESULT. A SECOND ANALYZER WAS USED, AND QCC 44 OCCURRED. THE CATHETER WAS MOVED FROM THE LEFT INTO THE RIGHT. THREE ANALYZERS AND 8 CARTRIDGES WERE USED BUT QCC 44 PERSISTED. AFTER SPEAKING WITH THE LAB AND ABBOTT IT WAS CONFIRMED THAT THE ANALYZERS WERE WORKING, AND THIS WAS LIKELY A HEMATOLOGIC PROCESS. WITH THE INABILITY TO GO BACK LEFT SIDED GIVEN SAFETY AND RISK OF CVA, THE DOCTOR AGAIN ATTEMPTED THE VOM. THEY WERE ABLE TO CANNULATE IT WITH A WIRE BUT NOT THE GUIDE CATHETER. AT THIS TIME, END TIDAL CO2 WAS ABOVE 50 AND DOCTOR DECIDED TO TERMINATE THE PROCEDURE. ALTHOUGH THERE IS NO EVIDENCE AN ADVERSE EVENT OCCURRED, IT WAS DETERMINED THAT A POTENTIAL DELAY HAD OCCURRED. THE PROCEDURE WAS CANCELED FOR THE PATIENT'S SAFETY, AS IT APPEARED THE PATIENT WAS HAVING AN ELECTIVE SURGERY AND THERE WERE NO REPORTS OF INJURY TO THE PATIENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. 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
    848680 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA R23063 10054749000149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown