BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3700785 · Received March 11, 2014

    Report

    Report Number
    2027969-2014-00210
    Event Type
    Death
    Date Received
    March 11, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 28, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED, VIA TELEPHONE CALL, THAT ON (B)(6) 2014 AT 11:00, A (B)(6) OLD MALE, (B)(6) PATIENT EXPERIENCED CHILLS, THREE (3) DARK TARRY STOOLS AND URINE WAS NOTED TO BE CLOUDY WITH SEDIMENT. THE INRATIO INR WAS 3.9 AND PROTHROMBIN TIME (PT) WAS 38.9. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0. AT 22:06, THE PATIENT EXPERIENCED BRIGHT RED BLOOD IN STOOL. ON (B)(6) 2014, THE PATIENT WAS BECOMING WEAKER AND A LITTLE MORE INCOHERENT. HE WAS HOSPITALIZED AT 10:42 WITH RECTAL BLEEDING AND UNRESPONSIVENESS. LABORATORY INR WAS 8.08, HEMAGLOBIN (HGB) 7.6 AND HEMATOCRIT (HCT) 24.7. TREATMENT OVER COURSE OF HOSPITALIZATION INCLUDED TRANSFUSION OF 6 UNITS FRESH FROZEN PLASMA (FFP), 4 UNITS PACKED RED BLOOD CELLS (PRBC), PROTONIX DRIP, ANTIBIOTICS, MONITORING OF HGB/HCT AND INTERNAL MEDICINE CONSULTATION. THE INR AT 21:10 WAS 2.31, HGB 8.2 AND HCT 25.8. THE PATIENT'S BLOOD COUNTS CONTINUED TO IMPROVE. NO FURTHER INR WAS PERFORMED. ON (B)(6) 2014 AT 00:05 PATIENT'S STATUS DECLINED AND CODE WAS CALLED. THE PATIENT WAS INTUBATED AND TROPONIN AT 00:20 WAS 7.147. THE URINE SHOWED ESCHERICHIA COLI (E. COLI). THE PATIENT EXPIRED ON (B)(6) 2014 AT 05:30. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146240 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 333655

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R INRATIO MONITOR: SN (B)(4)| COUMADIN 5MG DAILY| DULCOLAX SUPPOSITORY 10MG AS NEEDED| OMEPRAZOLE 20MG DAILY, STARTED| CEPHALEXIN 250MG TWICE DAILY, STARTED| KEPPRA 500MG TWICE DAILY| LOMOTIL 2 TABLETS AS NEEDED AFTER EACH LOOSE STOOL| EVERY FOUR HOURS AS NEEDED| HALDOL 1MG AS NEEDED| BUMEX 1MG TWICE DAILY| SENNA S, NIGHTLY| HYDROMORPHONE 4MG (5 TABLETS OR 20MG)