BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 2100359 · Received May 11, 2011

    Report

    Report Number
    2027969-2011-01045
    Event Type
    Other
    Date Received
    May 11, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON ON INRATIO TEST RESULT(S) WITH THE LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 4.0, REFERENCE: 5.8, MEAN: 4.9, CONFIDENCE LIMITS: 2.8 - 7.2, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PER TSR, USER REPORTED PATIENT HAS LUPUS. PER PRODUCT INSERT, "LUPUS OR ANTIPHOSPHOLIPID ANTIBODY SYNDROME (APS) MAY FALSELY PROLONG THE INR VALUE. TESTING WITH AN APS-INSENSITIVE LABORATORY METHOD IS RECOMMENDED FOR THESE PATIENTS." RETURNED PRODUCT WILL BE INVESTIGATED WHEN RECEIVED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 2.5. DATE: (B)(6) 2011, INRATIO: 4.0, LAB: 5.8. CUSTOMER IS NOT SURE WHICH STRIP LOT WAS USED FOR THIS TESTING. PATIENT REPORTS THAT HER INR HAS BEEN LOW ON THE METER SINCE JANUARY - GETTING 1.2, 1.2 ETC. PATIENT'S COUMADIN HAD BEEN ADJUSTED DURING THIS TIME BASED ON METER RESULTS. ADDITIONALLY, PATIENT REPORTS GETTING SCRATCHED BY A DOG ON (B)(6) 2011 WHICH LED TO BLEEDING THAT HASN'T STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other