BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1930536 · Received November 30, 2010

    Report

    Report Number
    2027969-2010-02078
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS TAKING ANTIBIOTICS AND PREDNISONE. PT'S CURRENT MEDICATION MAY INTERFERE WITH COAGULATION TEST. PT WAS ADMITTED ON (B)(6) 2010 DUE TO CHEST PAIN. PT CURRENT HEALTH STATUS AT THE TIME OF COAGULATION TEST MAY AFFECT TEST RESULT AND MAY LEAD TO INACCURATE OR UNEXPECTED INR RESULT. AS OF 11/30/2010, NO PRODUCT IS EXPECTED TO RETURN NOR STRIP LOT INFO WAS PROVIDED. UNABLE TO PERFORM IN-HOUSE INVESTIGATION. NO FURTHER INVESTIGATION WILL BE PURSUED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2010, INRATIO: 2.5, REFERENCE: 4.5, MEAN: 3.50, CONFIDENCE LIMITS: 2.0-5.0; DATE: UNK, INRATIO: 1.4, REFERENCE: 3.1*, MEAN: 2.25, CONFIDENCE LIMITS: 1.4-3.1; .*3.1 INR IS OBTAINED FROM DR'S METER (UNK BRAND). THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO STRIP LOT INFO WAS PROVIDED. PT'S OVER-ALL CONDITION MAY AFFECT INR TESTING. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING; CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: LAST WEEK, INRATIO: 2.5, LAB: 4.5; DATE: (B)(6) 2010, INRATIO: 1.4, DR'S METER: 3.1. PT RECENTLY HAD SURGERY, LAST HEPARIN DOSE 10/21 (BRIDGED FOR SURGERY). WAS DISCHARGED 10/29, BUT WAS RE-ADMITTED ON 11/1 FOR CHEST PAIN (HAS A HISTORY OF PULMONARY EMBOLISM). JUST FINISHED A Z-PAK OF ANTIBIOTICS YESTERDAY, AND IS ALSO ON PREDNISONE. PT STATES THAT SHE TAKES MAINTENANCE ANTIBIOTICS AND PREDNISONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1