BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4101578 · Received August 26, 2014

    Report

    Report Number
    2027969-2014-00784
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 29, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULTS IN COMPARISON TO THE LABORATORY (LAB) INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR STRIP LOT #315106 = 7.1 (EXPIRED STRIPS CASE: 00651402); INRATIO INR STRIP LOT #344281 = 3.1 AND >7.5 LABORATORY INR 10.4. THE TIME BETWEEN TESTING WAS ONE (1) HOUR. REPORTEDLY, PATIENT WAS SENT TO HOSPITAL WHERE LAB INR WAS 11.0, PATIENT WAS ADMINISTERED VITAMIN K AND JANTOVEN WAS HELD. PATIENT WAS HELD IN THE EMERGENCY ROOM (ER) UNTIL INR WAS WITHIN THERAPEUTIC RANGE OF 2.0-3.0, PATIENT WAS RELEASED (INR WAS 2.3) FROM EMERGENCY ROOM THE SAME DAY. ADDITIONALLY PATIENT REPORTED MULTIPLE FINGER STICKS PERFORMED ON THE SAME FINGER AND TOUCHING FINGER TO SAMPLE WELL. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518024 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 344281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RYTHMOL 225MG| ZANTAC 150MG| TRAMADOL 50MG| TYLENOL| DILTAZEM 120 MG| METROPOLOL 25 MG (TWICE A DAY)| JANTOVEN 2.5 MG| INRATIO MONITOR, SN: (B)(4)