BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 914704 · Received September 14, 2007

    Report

    Report Number
    2954730-2007-00435
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 12, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007, INRATIO: 0.8, LAB: 3.6, MEAN: 2.2, CONFIDENCE LIMITS: 1.4-3.1. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED. RETAINED STRIPS LOT 070325 TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE SYSMEX INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE SYSMEX INR SHALL BE +/- 0.5. IF THE SYSMEX INR IS 2.0 - 4.5, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE SYSMEX INR SHALL BE +/- 1.0. THE TEST RESULTS WERE REFERRED FROM CC # 7063. THE TEST RESULTS OF RETAINED STRIPS LOTS 070325 ON FIVE DAYS EARLIER, ARE AS FOLLOWS: LOT 070325: PATIENT 1: 3.1, SYSMEX INR: 3.2, DIFFERENCE: 0.1, RESULTS: PASS; LOT 070325: PATIENT 1: 2.9, SYSMEX INR: 3.2, DIFFERENCE: 0.3, RESULTS: PASS; LOT 070325: PATIENT 1: 3.0, SYSMEX INR: 3.2, DIFFERENCE: 0.2, RESULTS: PASS; LOT 070325: PATIENT 2: 3.1, SYSMEX INR: 2.8, DIFFERENCE: -.0.3, RESULTS: PASS; LOT 070325: PATIENT 2: 2.9, SYSMEX INR: 2.8, DIFFERENCE: -.0.1, RESULT: PASS; LOT 070325: PATIENT 2: 2.5, SYSMEX INR: 2.8, DIFFERENCE: 0.3, RESULT: PASS; BASED ON THE ABOVE TEST RESULTS, RETAINED LOT 070325 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007, INRATIO: 0.8, LAB: 3.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070325

    Patients

    Seq Age Sex Outcome Treatment
    1 YR