BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 4003031 · Received August 12, 2014

    Report

    Report Number
    2245578-2014-00040
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE INFORMATION ASSOCIATED WITH THE CUSTOMER'S REPORTED EVENT:PRODUCT NAME/ CATALOG #: I-STAT CARTRIDGE ACTC/ 03P86-25:LOT# LOT EXPIRATION MFG DATET14094 09/28/2014 04/04/2014T14094A 09/28/2014 04/04/2014

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 08/22/2014. A REVIEW OF TEST DATA, INCLUDING FINISHED GOODS, RETAIN, AND RETURN DATA, FOR ACT CELITE LOTS T14094 AND T14094A INDICATE THERE IS A HIGHER THAN EXPECTED RATE OF QUALITY CHECK CODES. HOWEVER, BASED ON THE QUALITY CHECK CODES OBSERVED IT IS UNLIKELY THAT A SIGNIFICANT DELAY WOULD BE EXPERIENCED AS ADDITIONAL CARTRIDGES CAN BE RUN TO OBTAIN A RESULT. THE ISSUE IS NOT SYSTEMIC IN THE CARTRIDGE LOT. THE I-STAT SYSTEM RUNS A COMPREHENSIVE SET OF QUALITY CHECKS OF ANALYZER AND CARTRIDGE PERFORMANCE EACH TIME A SAMPLE IS TESTED. THE INTERNAL QUALITY SYSTEM WILL SUPPRESS RESULTS IF THE ANALYZER OR CARTRIDGE DOES NOT MEET CERTAIN INTERNAL SPECIFICATIONS. TO MINIMIZE THE PROBABILITY OF DELIVERING A RESULT WITH MEDICALLY SIGNIFICANT ERROR THE INTERNAL SPECIFICATIONS ARE VERY STRINGENT. IT IS TYPICAL FOR THE SYSTEM TO SUPPRESS A VERY SMALL PERCENTAGE OF RESULTS IN NORMAL OPERATION GIVEN THE STRINGENCY OF THESE

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGE LOTS T14094 AND T14094A THAT YIELDED MULTIPLE QUALITY CHECK CODES (QCC) 25, QCC 22, QCC 44, AND QCC 46. THE CUSTOMER REPORTED THAT, DUE TO THE QUALITY CHECK CODES GENERATED, THEY HAD TO DELAY CARDIOPULMONARY BYPASS ON THE PATIENT. PER I-STAT SYSTEM MANUAL (ART: 714260-00P): CODE 44, & 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 & 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, HAS THE POTENTIAL FOR A SIGNIFICANT DELAY BASED ON THE AVAILABLE INFORMATION. THE CUSTOMER EXPERIENCED A HIGHER RATE OF QUALITY CHECK CODES THAN EXPECTED. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. BASED ON THE INFORMATION AT THIS TIME THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478598 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1