BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 2967670 · Received February 19, 2013

    Report

    Report Number
    2245578-2013-00013
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. ALTHOUGH TESTING PASSED ACCEPTANCE CRITERIA, A DEFICIENCY WAS DISCOVERED THAT IS ASSOCIATED WITH THE LOT IN QUESTION. GATHERED PROCESS TEST DATA INCLUDING FINISHED GOODS RETAIN AND RETURN DATA FOR ACT CELITE S12252 SHOWS THE INITIAL OSCILLATION MEASUREMENT CAN BE A PREDICTOR FOR INCREASED RATES OF CODES LIKE QC CODE 31. THE ISSUE IS NOT UNIFORMALLY DISTRIBUTED ACROSS LOT S12252.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGE LOT# S12252 THAT YIELDED QUALITY CHECK CODE 44 (QCC) AND QCC 81 WHILE TESTING VETERINARY PATIENTS. PER I-STAT SYSTEM MANUAL (ART: (B)(4)). QCC 44: 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 81: CARTRIDGE ERROR - BAD CONTACT BETWEEN THE THERMAL PROBES IN THE ANALYZER AND THE METALIZATION ON THE BACK OF THE CHIPS IN THE CARTRIDGE TRIGGER THESE CODES. CAUSES ARE: POOR METALIZATION OF THE CHIPS, DIRT ON THE METALIZATION, OR BENT OR BROKEN THERMAL PROBES IN THE ANALYZER. BASED ON THE INFORMATION AVAILABLE THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71068 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA S12252

    Patients

    Seq Age Sex Outcome Treatment
    1