BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2030236 · Received March 21, 2011

    Report

    Report Number
    2027969-2011-00560
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 23, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS OF CUSTOMER'S RESULTS WAS NOT PERFORMED SINCE BOTH INRATIO AND REFERENCE TEST RESULTS WERE PERFORMED TWO DAYS APART. SINCE TIME BETWEEN TESTS EXCEEDED THREE HRS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HRS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. NO PRODUCT IS EXPECTED TO BE RETURNED. FURTHER INVESTIGATION COULD NOT BE PERFORMED SINCE NO STRIP LOT INFO WAS PROVIDED BY THE CUSTOMER. THIS COMPLAINT 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. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.7, LAB: NG. DATE: (B)(6) 2011, INRATIO: NG, LAB: 2.1. DATE: (B)(6) 2011, INRATIO: 4.0, LAB: NG. DATE: (B)(6) 2011, INRATIO: NG, LAB: 2.7. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    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 NI