BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOSIL RECOMBIPLASTIN 2G

    MDR report key: 1258169 · Received November 25, 2008

    Report

    Report Number
    2431530-2008-00001
    Event Type
    Other
    Date Received
    November 25, 2008
    Date of Event
    June 18, 2008
    Report Date
    November 25, 2008
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    PMA / PMN Number
    K070005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE EVENT BASED ON THE EVENT DESCRIPTION RECEIVED THROUGH THE PHARMACEUTICAL MFR'S (B)(4) MEDWATCH REPORT (REFERENCE MFR REPORT #(B)(4)). NO MALFUNCTION BASED ON INTERNAL TESTING OF IDENTIFIED PRODUCT LOT OF HEMOSIL RECOMBIPLASTIN 2G (PN:0020003050, LOT#:N1175214), WHICH DOES NOT INDICATE INTERFERENCE UP TO THE EXPECTED PEAK DOSE FOR CUBICIN (75UG/ML). BASED ON THE INTERNAL TESTING PERFORMED, THIS APPEARS TO BE AN ISOLATED ANOMALY SPECIFIC TO THIS PT SAMPLE. NO REMEDIAL ACTION IS INTENDED.

    Description of Event or Problem · 1

    INSTRUMENTATION LAB RECEIVED A NOTIFICATION FROM (B)(6) ON (B)(6) 2008 THAT A POSSIBLE DRUG INTERFERENCE OCCURRED INVOLVING A PT ON CUBICIN (DAPTOMYCIN FOR INJECTION) THERAPY. THE REAGENT USED BY THE HOSP LAB WAS RECOMBIPLASTIN 2G. PLEASE SEE MFR REPORT #(B)(4) FOR COMPLETE DETAILS OF THE PROBLEM DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSIL RECOMBIPLASTIN 2G PROTHROMBIN TIME TEST JPA INSTRUMENTATION LABORATORY CO. NA N1175214

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR