BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 2958618 · Received February 13, 2013

    Report

    Report Number
    2245578-2013-00008
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. CUSTOMER RETURNS AND RETAINED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGE LOT# S12254 THAT YIELDED FIVE CONSECUTIVE QUALITY CHECK CODE 31 (QCC), QCC 39 AND QCC 22 WHILE TESTING A PATIENTS. THE CUSTOMER STATES THAT THE SAMPLES ARE COLLECTED IN PLASTIC SYRINGES AND THE BLOOD BANK PERSONNEL ARE RESPONSIBLE FOR THE RUNNING OF THE ACT CARTRIDGES FOR THE CATHLAB. THE 15% RATE OF QUALITY CHECK CODES WAS OVER A TWO WEEK PERIOD. THE CUSTOMER IS RETURNING CARTRIDGES FOR INVESTIGATION. PER I-STAT SYSTEM MANUAL (ART: (B)(4)). QCC 22: CARTRIDGE ERROR - THESE CODES OCCUR ONLY FOR COAGULATION CARTRIDGES IF THE MIXING OF THE SAMPLE AND REAGENT IS COMPROMISED. THIS CAN BE CAUSED BY AN INSUFFICIENT OR CLOTTED SAMPLE, OR BY AIR BUBBLES IN THE SAMPLE. QCC 31: UNABLE TO POSITION - THE ANALYZER DID NOT DETECT MOVEMENT OF SAMPLE ACROSS THE SENSORS. THIS COULD BE DUE TO A CLOT IN THE SAMPLE (ESPECIALLY IN NEONATES), TO NOT CLOSING THE SNAP CLOSURE ON THE CARTRIDGE, OR TO AN ABERRANT CARTRIDGE. QCC 39: INSUFFICIENT SAMPLE - THIS IS MOST LIKELY DUE TO INSUFFICIENT SAMPLE IN THE SAMPLE WELL OF THE CARTRIDGE, BUT CAN ALSO BE CAUSED BY BUBBLES IN THE SAMPLE. TRY ANOTHER CARTRIDGE AND ENSURE SUFFICIENT SAMPLE IS IN THE SAMPLE WELL. BASED ON THE INFORMATION AVAILABLE THERE IS REASON TO BELIEVE THAT THERE IS A HIGHER THAN EXPECTED RATE OF FAILURE. THERE ARE NO INJURIES REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64014 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA S12254

    Patients

    Seq Age Sex Outcome Treatment
    1