BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 15279022 · Received August 23, 2022

    Report

    Report Number
    2245578-2022-00114
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 25, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    UDI-DI
    10054749000156
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 20-OCT-2022. 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 12-AUG-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RUN, TIME, RESULT. 1ST RUN, 1504H, 250 SECONDS. 2ND RUN, 1552H , >1000 SECONDS. 3RD RUN, 1559H, 181 SECONDS. 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 AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2822373 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA R22131 10054749000156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown