BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 5060227 · Received September 8, 2015

    Report

    Report Number
    2245578-2015-00047
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    PMA / PMN Number
    K020355
    Removal / Correction Number
    APOC2015-002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. APOC PRODUCT ACTION NUMBER: (B)(4). LOT NUMBERS: ALL LOTS FROM S15007 TO S15026 INCLUSIVE, AND ALL LOTS FROM T15037A TO T15076A INCLUSIVE.

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT CERTAIN LOTS OF I-STATT/INR CARTRIDGES MAY GENERATE A HIGHER THAN TYPICAL NUMBER OF PT/INR STAR OUTS. THE I-STAT SYSTEM AUTOMATICALLY RUNS A COMPREHENSIVE SET OF QUALITY CHECKS OF ANALYZER AND CARTRIDGE PERFORMANCE EACH TIME A SAMPLE IS TESTED. THIS INTERNAL QUALITY SYSTEM WILL SUPPRESS RESULTS IF THE ANALYZER OR CARTRIDGE DOES NOT MEET CERTAIN INTERNAL SPECIFICATIONS. IT IS TYPICAL FOR THE SYSTEM TO SUPPRESS A VERY SMALL PERCENTAGE OF RESULTS IN NORMAL OPERATION GIVEN THE STRINGENCY OF THESE SPECIFICATIONS. STARS APPEAR IN PLACE OF RESULTS ON THE HANDHELD DISPLAY IF THE ANALYZER DETECTS THAT THE SENSOR'S SIGNAL IS UNCHARACTERISTIC ABBOTT POINT OF CARE HAS DETERMINED THAT THERE IS A POTENTIAL TO DELAY THE GENERATION OF PATIENT RESULTS FOR PT/INR DUE TO THE STAR OUTS. WHEN RESULTS ARE GENERATED THEY ARE WITHIN THE EXPECTED PERFORMANCE OF THE ASSAY. ABBOTT POINT OF CARE MADE THE DECISION TO COMMUNICATE THIS INFORMATION TO THE POTENTIALLY AFFECTED MARKETPLACE. THIS COMMUNICATION WAS NOT PERFORMED TO REDUCE RISK TO HEALTH. ABBOTT POINT OF CARE HAS MADE THE DECISION TO COMMUNICATE THIS INFORMATION TO THE AFFECTED MARKETPLACE TO ENSURE THE PERFORMANCE OF OUR PRODUCT. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591776 I-STAT PT/INR CARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1