BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2010218 · Received February 11, 2011

    Report

    Report Number
    2027969-2011-00305
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 10, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON CUSTOMER'S RESULTS SINCE 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 PATIENT. THREE HOURS 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. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT ACCURACY CRITERIA WAS MET. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. NO FURTHER INVESTIGATION REQUIRED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT #232886. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 232886 ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0). NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.0, LAB: NG. ON (B)(6) 2011, NG, 2.5. PATIENT'S THERAPEUTIC RANGE: 2-2.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 232886

    Patients

    Seq Age Sex Outcome Treatment
    1 NI