BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2043651 · Received March 29, 2011

    Report

    Report Number
    2027969-2011-00646
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS PERFORMED ON INRATIO PRECISION DATA PROVIDED BY END-USER LOT. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, 1ST INR: 4.2, 2ND INR: 2.5, MEAN: 3.35, SD: 1.20, %CV: 35.88. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT #241836 FROM (B)(6) 2011 MET PRECISION CRITERIA. DONOR 1, 1ST INR: 3.6, 2ND INR: 3.7, 3RD INR: 3.5, MEAN: 3.6, SD: 0.10, %CV: 2.78. DONOR 2, 1ST INR: 2.1, 2ND INR: 2.2, 3RD INR: 2.1, MEAN: 2.13, SD: 0.06, %CV: 2.71. SINCE % CV IS LESS THAN 16%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TEST RESULT COMPARISON MET PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. (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.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, 1ST INRATIO: 4.2; 2ND INRATIO: 2.5. IMMEDIATE RETEST ON DIFFERENT FINGER AND SAME HAND. PT'S THERAPEUTIC RANGE: (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 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI