BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 4346762 · Received December 19, 2014

    Report

    Report Number
    2245578-2014-00086
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    December 8, 2014
    Report Date
    December 8, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 03/16/2015. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. RETAIN CARTRIDGES WERE TESTED IN WHOLE BLOOD (WB) AND WHOLE BLOOD SPIKED TO 5U/ML HEPARIN (S5) TEST FLUIDS. THE CUSTOMER COMPLAINT WAS REPRODUCED WITH S5. ACT CELITE CARTRIDGE LOT T14297 WAS BRACKETED UNDER EXCEPTION REPORT# 365457 FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NA

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGE THAT YIELDED UNEXPECTED RESULTS ON A PATIENT UNDERGOING A PROCEDURE IN THE CATH LAB. THE PATIENT HAD BEEN ADMITTED FOR EPS/RFA FOR ATRIAL FIBRILLATION AND ATRIAL FLUTTER. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TIME: 1038, ACT: N/A, RESULT: 5,500 UNITS OF HEPARIN ADMINISTERED; 1045, N/A, 5,500 UNITS OF HEPARIN ADMINISTERED; 1105, 368; 1121, 285; 1136, 350; 1137, 231; 1320, 260. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838875 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA T14297

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR