BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2026598 · Received March 16, 2011

    Report

    Report Number
    2027969-2011-00512
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INR RESULTS PROVIDED BY CUSTOMER ARE PERFORMED MORE THAN THREE HOURS BETWEEN TWO READINGS. SINCE TIME OF TEST 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 COMPARISON TO BE VALID. DATA ANALYSIS WILL NOT BE PERFORMED AND NO FURTHER INVESTIGATION WILL BE PURSUED. RECENT TEST CONDUCTED ON (B)(6) 2011 FOR LOT #243934 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2011, DONOR: #1, INR RESULTS: (3.4, 3.2, 3.2). DATE: (B)(6) 2011, DONOR: #2, INR RESULTS: (3.8, 4.0, 3.7). AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (^+/- 1.0) OF REFERENCE RESULTS FOR DONOR 1 (2.70 INR) AND DONOR 2 (2.96 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). THERE IS NO INDICATION IN THE TRENDING DATA THAT THERE IS AN ELEVATED INCIDENCE OF DISCREPANT RESULTS WITH THIS LOT. THEREFORE, THERE IS NO INCREASED RISK OF PATIENT RECEIVING INAPPROPRIATE TREATMENT BECAUSE OF USING LOT# 243934. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE CORRECTIVE ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, LAB: 2.53. DATE: (B)(6) 2011, INRATIO: 1.8. THERAPEUTIC RANGE: (2.0-3.0). NO CHANGE IN MEDICATION OR DIET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI