BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3925385 · Received June 16, 2014

    Report

    Report Number
    2027969-2014-00579
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE CUSTOMER MISINTERPRETED THE ICONS DISPLAYED ON THE INSTRUMENT. THE USER GUIDE FOR THE INRATIO2 PT/INR MONITOR DISCUSSES THE MEANING OF THE DISPLAYED SYMBOLS FOR TROUBLESHOOTING. NO RESULTS WERE DISPLAYED ON THE SCREEN. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. A REVIEW OF THE BATCH RECORD FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE PRODUCT WAS FOUND TO MEET SPECIFICATIONS AND NO DEFICIENCY WAS ESTABLISHED. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT ON (B)(6) 2014, THEY RECEIVED A MESSAGE OF "HI" DISPLAYED ON THE INSTRUMENT AND HELD THE PT'S COUMADIN AS A RESULT. THE NURSE ORDERED A STAT LABORATORY INR AT THE SAME TIME. THE STAT LABORATORY RESULT WAS 1.6 HOWEVER, IT WAS NOT RECEIVED UNTIL (B)(6) 2014. THE PT'S COUMADIN WAS THEN INCREASED TO 6MG. A RECHECK OF THE INR WAS PERFORMED ON (B)(6) 2014. REPORTEDLY, LOVENOX HAS BEEN USED INTERMITTENTLY FOR TWO (2) WEEKS. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351938 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 343286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COUMADIN, 6 MG (B)(6) 2014| COUMADIN HELD X 2 DAYS| LOVENOX| INRATIO MONITOR: SN (B)(4)| LOVENOX 60 MG X 4 DAYS| COUMADIN 6 MG| LOVENOX 60 MG (B)(6) 2014| COUMADIN 5 MG| COUMADIN 2 MG, INCREASED TO 4 MG