BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 2578554 · Received May 14, 2012

    Report

    Report Number
    2245578-2012-00333
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 16, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT# S11287, MFR DATE: 10/2011, EXPIRATION DATE: 03/28/2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED MULTIPLE QUALITY CHECK CODE (QCC) 31 DURING A PROCEDURE. CUSTOMER WAS USING LOTS S11321A & S11287. CUSTOMER STATES THAT HE TRIED RECOLLECTING THE SAMPLE FROM A LINE WITH A SYRINGE INTO CARTRIDGE 8 TIMES AND GOT QCC 31 ON ALL 8 CARTRIDGES. CAUSING A DELAY IN TREATMENT OF A PT SINCE THE I-STAT IS THE ONLY METHOD FOR TESTING ACT AT THE CUSTOMER SITE. ART: (B)(4) IN THE I-STAT SYSTEM MANUAL DEFINES QCC 31 AS "UNABLE TO POSITION SAMPLE" ERROR. THE ANALYZER DID NOT DETECT MOVEMENT OF SAMPLE ACROSS THE SENSORS. THIS COULD BE DUE TO COLT IN THE SAMPLE (ESPECIALLY IN NEONATES), TO NOT CLOSING THE SNAP CLOSURE ON THE CARTRIDGE, OR TO AN ABERRANT CARTRIDGE. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. AN INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA S11321A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA