BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1847737 · Received September 23, 2010

    Report

    Report Number
    2027969-2010-01547
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 23, 2010
    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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH INR RESULTS PROVIDED BY CUSTOMER WERE PERFORMED MORE THAN THREE HOURS APART. SINCE TIME OF TEST 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 THE COMPARISON TO BE VALID. DATA ANALYSIS WILL NOT BE PERFORMED AND NO FURTHER INVESTIGATION WILL BE PURSUED. NO PRODUCT IS EXPECTED TO BE RETURNED. AS OF 09/23/2010, TEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.007%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. 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) 2010, INRATIO: 4.4, LAB: 3.3. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1 NI