BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2154496 · Received June 28, 2011

    Report

    Report Number
    2027969-2011-01421
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. ADD'L LOT #251117.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: >7.5, LAB: 3.3. CUSTOMER STARTED HAVING ISSUES WITH PATIENT'S BEING TESTED ON TWO DIFFERENT METERS AND TWO DIFFERENT STRIP LOTS. CUSTOMER STATED GETTING THAT THEY JUST STARTED GETTING >7.5 INR RESULTS WITH 3 PATIENTS USING STRIP LOT 253026 WITH METER SERIAL #(B)(4) YESTERDAY AND 4 DIFFERENT PATIENTS USING STRIP LOT 251117 WITH METER SERIAL #(B)(4) TODAY. THEY DID HAVE THE PATIENTS TEST IMMEDIATELY AT THE LAB (WITHIN 15 MINUTES) AND RESULTS WOULD BE IN THEIR TARGET RANGE. FOR EXAMPLE, 1 PT WHO GOT >7.5 ON THE METER WENT TO THE LAB= 3.3 INR. CUSTOMER DID NOT PROVIDE INFO ABOUT WHICH STRIP LOT AND METER WERE USED. NO OTHER DATA PROVIDED FROM OTHER PATIENTS. CALLER CONFIRMED, SHE COMPLETED A SELF TEST WITH METER SN (B)(4) AND GOT 0.9 INR AS RESULT USING STRIP LOT 253026. THEN SHE HAD ANOTHER NURSE TEST HERSELF ON THE METER AND GOT 1.1 INR. SHE DID NOT KNOW IF NURSE USED A DIFFERENT STRIP LOT OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1