BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4023895 · Received August 13, 2014

    Report

    Report Number
    2027969-2014-00753
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2014; INRATIO: 4.0; RE-TEST: 4.0; LAB: 19.0; TIME BETWEEN TESTS: MINUTES. THERAPEUTIC RANGE: 2.0-3.0. ON (B)(6) 2014: PT HAD A ONE MONTH FOLLOW UP APPOINTMENT WITH DR (B)(6) TO DISCUSS HISTORY AND HOSP ISSUES. THE PT HAS NOT BEEN FEELING WELL FOR A FEW DAYS, WITH AN OFF AND ON FEVER, SORE THROAT AND ABDOMINAL PAIN. IN ADDITION THE PT'S GERD AND STOMACH HAVE ACTING UP; NO VOMITING OR DIARRHEA. THE PT'S INR WAS DRAWN TODAY; INR=7.5. HER LAST INR DRAW WAS 1.6 AND OVER 5 THE WEEK BEFORE. THE PT REPORTS THAT HER GUMS HAVE BEEN BLEEDING A LITTLE WITH TOOTHBRUSHING, BUT NO OTHER REPORTS OF BLEEDING. THERE HAS BEEN NO CHANGE IN SHORTNESS OF BREATH (SOB). THE PT HAS CONTINUED TO TAKE PROTHROMBIN TIME (PT) AT HOME AND CAN ONLY DO SHORT BURSTS OF ACTIVITY. THE PT'S VITAMIN D LEVEL IS TO BE CHECKED AS SHE HAD AN INFUSION OF IT RECENTLY. THE DOCTOR DISCUSSED TREATMENT OPTIONS WITH THE PT, INCLUDING HOSPITALIZATION. THE PT DECLINED BEING ADMITTED TO THE HOSP. AND WAS GIVEN 500MG VITAMIN K BY MOUTH. THE DOCTOR WILL TRY TO BRING THE PT'S INR DOWN SLIGHTLY WITHOUT DROPPING IT SUB-THERAPEUTIC. THE PT WILL NOT BE TAKING COUMADIN THIS WEEK. THE DOCTOR ALSO DISCUSSED THAT FLUCONAZOLE WILL ALSO POTENTIALLY INCREASE INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483070 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 343592

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention PREDNISONE 32.5| SPIRONOLACTONE 50MG| ALBUTEROL| FERROUS SULFATE 325MG| FENTANYL| PROTONIX 40MG| SPRIVA 18MCG| ZOFRAN 4MG| MEXILETINE 25MG| TOPROL XL 50MG| CULTURELLE| LASIX| FLUCONAZOLE 100MG| ERGOCALCIFEROL 50,00U| COLCHICINE| SYMBICORT| GABAPENTIN 300MG| TYLENON 650 MG| MORPHINE 30MG| LYRICA 25MG| VANCOCIN 125MG| COUMADIN| INRATIO MONITRO, SN 092052367| INVANZ 1,00MG IN SODIUM CHLORIDE