BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT BNP CARTRIDGE

    MDR report key: 2553741 · Received April 13, 2012

    Report

    Report Number
    2245578-2012-00317
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    January 30, 2012
    Report Date
    April 4, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJX
    PMA / PMN Number
    K053597
    Removal / Correction Number
    APOC2012-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, THE INCIDENT WAS IDENTIFIED AND LINKED TO AN INVESTIGATION COMPLETED ON (B)(4) 2011 AND WHERE DEFICIENCY WAS IDENTIFIED THAT FURTHER LED TO REMEDIAL ACTION FILED ON (B)(4) 2012. THROUGH A COMBINATION OF INTERNAL STUDIES AND CUSTOMER REPORTS, ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT THE FREQUENCY OF SUPPRESSED RESULTS FOR I-STAT CTNI, BNP, AND CK-MB ARE AFFECTED BY ATMOSPHERIC PRESSURE. SUPPRESSED RESULT RATES MAY INCREASE WITH HIGHER ELEVATIONS (DECREASED BAROMETRIC PRESSURE) AND MAY BECOME PERSISTENT IF TESTING IS PERFORMED AT MORE THAN 7500 FEET ABOVE SEA LEVEL. THE PRESSURE EFFECTS THAT LEAD TO THE INCREASED SUPPRESSED RESULT RATE DO NOT AFFECT THE ANALYTICAL RESULTS OF THE ASSAY WHEN GENERATED. THIS ACTION WAS CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT BNP CARTRIDGE THAT ARE YIELDING A HIGH RATE FOR QUALITY CHECK CODES (QCC) 50, 123, 129, AND 142. THE CUSTOMER WAS RUNNING QUALITY CONTROL MATERIAL DURING THIS TIME AND THERE WERE NO PT OR INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION WAS COMPLETED ON (B)(4) 2012 AND ALTHOUGH RETAINED AND RETURNED CARTRIDGE TEST RESULTS DEMONSTRATE THAT BNP CARTRIDGE LOT B11263 CONTINUES TO PERFORM ACCORDING TO SPECIFICATIONS WHEN USED AT ELEVATIONS NEAR SEA LEVEL, THE ELEVATION AT THE CUSTOMER'S SITE IS (B)(6). THEREFORE, LINKED TO PRODUCT ACTION OUTLINED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT BNP CARTRIDGE BNP CARTRIDGE JJX ABBOTT POINT OF CARE INC. NA B11263

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK