BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2822000 · Received October 1, 2012

    Report

    Report Number
    2027969-2012-01424
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 1, 2012
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (PRECISION) COMPARISON OF INRATIO TEST. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 1.0, INRATIO: 2.2, MEAN: 1.6, %CV: 53.03. THE RESULTS ARE CONSIDERED DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. USER REPORTED MILKING PATIENT'S FINGER IN THE ATTEMPT TO COLLECT A SUFFICIENT SAMPLE FOR THE TEST. PER PRODUCT USER GUIDE, REPETITIVE PRESSURE TO COLLECT THE DROP OF BLOOD." MILKING THE FINGER CAN CAUSE INTERSTITIAL FLUID CONTAMINATION, LEADING TO PRE-ANALYTICAL ERRORS. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT # 284358. RESULTS AS FOLLOWS: DONOR 1: INRATIO: 1.9, INRATIO: 1.9, INRATIO: 2.0, REFERENCE: 1.70, %CV: 2.99. DONOR 2: INRATIO: 2.8, INRATIO: 2.7, INRATIO: 2.6, REFERENCE: 2.39, %CV: 3.70. THE PRODUCT WAS NOT EXPECTED TO BE RETURNED; THEREFORE, RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RESULTS FROM RETAIN STRIP TESTING ON IN-HOUSE METERS MET PRECISION CRITERIA. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4). NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, INRATIO: 1.0, INRATIO: 2.2. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS ONE MINUTE. PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 284358

    Patients

    Seq Age Sex Outcome Treatment
    1 NI