BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2003204 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00326
    Event Type
    Other
    Date Received
    February 15, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED FOR TESTS DONE ON THE 13TH BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. CUSTOMER WAS ALSO ON ANTIBIOTICS ON THE 13TH. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." DATA ANALYSIS WAS NOT PERFORMED FOR TESTS DONE ON THE 18TH BECAUSE OF IMPROPER TECHNIQUE. CUSTOMER USED BLOOD FROM THE SYRINGE FOR TESTING. PER PRODUCT USER GUIDE, "USE ONLY FRESH CAPILLARY BLOOD FOR TESTING," THIS WOULD CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. PATIENT IS ANEMIC. PT'S CURRENT HEALTH STATUS MAY AFFECT COAGULATION TEST AND CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. PER PRODUCT USER GUIDE - LIMITATIONS, HEMATOCRIT RANGES BETWEEN 30-55% WILL NOT AFFECT TEST RESULTS." PREVIOUS INVESTIGATION OF STRIP LOT 233029 FROM ANOTHER COMPLAINT MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. FOR PREVIOUS COMPLAINT, TWO THERAPEUTIC DONORS WERE TESTED USING RETAINED STRIPS, RETURNED METER (FROM THAT COMPLAINT), IN-HOUSE AND REFERENCE METERS. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 233029 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA; NO FURTHER ACTION IS REQUIRED. (B)(4). ACTION THRESHOLD HAS BEEN REACHED. SINCE STRIP LOT RELEASED, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. 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. THERAPEUTIC RANGE 2-3. PT JUST FINISHED ANTIBIOTICS; WAS ON THEM FOR THE TEST ON THE 13TH BUT NOT FOR THE ONE ON THE 18TH. PT IS ANEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other