BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 2958581 · Received February 13, 2013

    Report

    Report Number
    2245578-2013-00011
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. RETAIN TESTING WAS COMPLETED AND PRODUCT IS PERFORMING AS INTENDED. HOWEVER, TESTING OF CUSTOMER RETURNED CARTRIDGES SHOW A HIGHER RATE OF QUALITY CHECK CODES (QCC) THAN EXPECTED. GATHERED PROCESS TEST DATA INCLUDING FINISHED GOODS, RETAIN AND RETURN DATA FOR ACT KAOLIN S12276 SHOWS THE INITIAL OSCILLATION MEASUREMENT CAN BE A PREDICTOR FOR INCREASED RATES OF CODES LIKE QCC CODE 31. THE ISSUE IS NOT UNIFORMLY DISTRIBUTED ACROSS LOT S12276. FURTHER EVALUATION HAS BEEN INITIATED TO ARRIVE AT, OR DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED MULTIPLE QUALITY CHECK CODES 31, QCC 25, QCC 22, QCC 44, AND QCC 46 WITH ACT-K CARTRIDGE LOT # S12276. ON MULTIPLE PATIENTS. 9 - QCC 31 OUT OF 44 CARTRIDGES = 20%, 6 - QCC 25 OUT OF 44 CARTRIDGES = 14%, 1 - QCC 22, 1 - QCC 44, 1 - QCC 46. PER I-STAT SYSTEM MANUAL (ART: (B)(4)). CODE 31, 44, AND 46 UNABLE TO POSITION SAMPLE/ CARTRIDGE ERROR: 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. CODE 22 AND 25, 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. ABBOTT POINT OF CARE HAS DETERMINED THE EVENT AS STATED BY THE CUSTOMER, A POTENTIAL FOR A SIGNIFICANT DELAY BASED ON THE AVAILABLE INFORMATION. THE INFORMATION PRESENTS A HIGHER RATE OF QUALITY CHECK CODES THAN EXPECTED. THE CUSTOMER DOES NOT PROVIDE PATIENT INFORMATION. BASED ON THE INFORMATION AT THIS TIME THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62455 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE NA S12276

    Patients

    Seq Age Sex Outcome Treatment
    1