BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    MDR report key: 3872106 · Received April 17, 2014

    Report

    Report Number
    2027969-2014-00349
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 8, 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
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. ON (B)(6) 2014, A (B)(6) MALE PRESENTED TO HIS PRIMARY CARE PHYSICIAN'S OFFICE FOR AN EVALUATION FOR LIVER BIOPSY RELATED TO ELEVATED LIVER FUNCTION TESTS AND A COLONOSCOPY RELATED TO A NEW ONSET OF RECTAL BLEEDING. THE LABORATORY INR WAS PERFORMED IN ADDITION TO NORMAL BLOOD WORK FOR CHECKUP. LABORATORY RESULTS AT 14:35 ARE AS FOLLOWS: INR=14.2 AND PROTHROMBIN TIME (PT)=161.9. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 3.0. APPROXIMATELY 15:10, THE INRATIO2 INR WAS PERFORMED AT AN ANTICOAGULATION "COUMADIN" CLINIC. THE RESULT WAS 2.3. REPORTEDLY, THE MONITOR WAS NOT IN THE CORRECT MODE WHEN THE FINGER STICK WAS PERFORMED AND THE SAMPLE WAS NOT IMMEDIATELY APPLIED TO THE SAMPLE WELL. IN ADDITION, A CAPILLARY TUBE WAS USED TO OBTAIN SAMPLE. THE PATIENT WAS HOSPITALIZED AFTER RECEIVING THE LABORATORY INR RESULT. IN THE HOSPITAL, THE LABORATORY RESULTS WERE AS FOLLOWS: (17:45) INR=15.9; PT=180.2 (19:45) INR=12.1; PT=137.2; PARTIAL THROMBOPLASTIN TIME (PTT)=75; HEMOGLOBIN (HGB)=16.7; HEMATOCRIT (HCT)=46.4. URINALYSIS, PERFORMED ON (B)(6) 2014, SHOWED THE URINE TO BE RED IN COLOR WITH A LARGE AMOUNT OF OCCULT BLOOD. THE PATIENT'S COUMADIN WAS HELD AND VITAMIN K 10MG WAS ADMINISTERED INTRAVENOUSLY (IV). ON (B)(6) 2014 AT 06:38, LABORATORY RESULTS AS FOLLOW: INR=2.0; PT=21.7; HGB=15.3 AND HCT=43.4 CONSULTATION NOTES, DATED (B)(6) 2014, INDICATED THAT THE PATIENT WAS TO HAVE A COLONOSCOPY PERFORMED PRIOR TO DISCHARGE ON (B)(6) 2014 AND LIVER BIOPSY TO BE PERFORMED ON AN OUTPATIENT BASIS. ON (B)(6) 2014 AT 07:39, LABORATORY RESULTS AS FOLLOWS: INR=1.3; PT=13.4; HGB=15.4; AND HCT=43.6. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235721 INRATIO2 PT/INR PROFESSIONAL TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 226668

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R METOPROLOL SUCCINATE XL: 100MG DAILY| ASPIRIN: 81MG DAILY| DILTIAZEM CD: 240MG DAILY| SPIRONOLACTONE: 25MG DAILY| NORCO: 5/325MG 1 TAB AS NEEDED| INRATIO MONITOR: SN (B)(4)| AMBIEN: 5 MG BEDTIME AS NEEDED| BUMETANIDE: 1MG TWICE DAILY| COUMADIN: 3MG