BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 16137496 · Received January 11, 2023

    Report

    Report Number
    2245578-2023-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    November 23, 2022
    Report Date
    March 1, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    UDI-DI
    10054749000156
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 28-FEB-2023. 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. AK (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 KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT OF >1000 ON A 75 YEAR FEMALE PATIENT DURING A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED ACT (SEC). I-STAT ON (B)(6) 2022 13:58 173, I-STAT ON (B)(6) 2022 14:12 144, I-STAT ON (B)(6) 2022 14:18 155, I-STAT ON (B)(6) 2022 14:39 >1000. PER I-STAT SYSTEM MANUAL (ART: 770715-00A), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLINACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE CUSTOMER ALLEGES A FALSELY DEPRESSED RESULT OF 155 SECONDS AFTER DOSING THE PATIENT WITH NO INCREASE. FOLLOWING AN EXTRA BOLUS, THE ACT WENT TOO HIGH AND RESULTED IN >1000 SECONDS. THERE WERE NO DETAILS/TIMES PRESENTED FOR HEPARIN AND LIMITED PATIENT INFORMATION. IT IS SUSPECTED THAT THE PATIENT MAY BE HEPARIN RESISTANT. AN INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420211 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA R22216 10054749000156

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female