BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STAT ACT CELITE CARTRIDGES

    MDR report key: 2366299 · Received December 6, 2011

    Report

    Report Number
    2245578-2011-00395
    Event Type
    Injury
    Date Received
    December 6, 2011
    Date of Event
    November 23, 2011
    Report Date
    November 23, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. PRELIMINARY FG TESTING SHOWS NO DEFICIENCIES. FULL INVESTIGATION PENDING. PRELIMINARY ON RETAIN TESTING WAS COMPLETED ON (B)(4) 2011 FOR LOT S11250A. RETAIN TESTING OF 45 CARTRIDGES SHOWED THAT LOT S11250A IS PERFORMING TO SPECIFICATION. THE FULL INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT CELITE CARTRIDGES THAT ON OR ABOUT (B)(6) 2011 THE OPERATING ROOM STAFF STARTED NOTICING THAT ACT READINGS WERE NOT AS HIGH AS THEY WERE ACCUSTOMED TO SEEING, USUALLY 250-300. USUALLY 5000-7000 UNITS OF HEPARIN ARE GIVEN NOW GIVING 10000-12000 OR MORE TO REACH AN ACT OF 250-300. CUSTOMER REPORTED A PATIENT THAT HAD A STROKE AFTER PERFORMING ACT-C CARTRIDGES IN THE OPERATING ROOM. THE PATIENT WAS GIVEN 11000 UNITS OF HEPARIN, ACTS WERE 221, 209, AND 246. THE PATIENT HAD A STROKE THAT CUSTOMER FEELS WAS CAUSED BECAUSE THE ACT-C RESULTS DID NOT RESPOND TO HEPARIN CAUSING AN EMBOLIC CLOT WITH THE CUSTOMER INDICATING THEY DID NOT KNOW IF THE PATIENT WAS PROPERLY ANTI-COAGULATED. APOC BELIEVES THAT THE ACT-C RESPONDED TO THE HEPARIN THOUGH PERHAPS NOT AS THE CUSTOMER EXPECTED OR WANTED TO SEE. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO FURTHER INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT CELITE CARTRIDGES ACT CELITE CARTRIDGES JBP ABBOTT POINT OF CARE INC. NA S11250A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK