BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000607 · Received February 2, 2011

    Report

    Report Number
    2027969-2011-00245
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 2, 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
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER. 1ST INR: 7.5; 2ND INR: 2.0; 3RD INR: 1.7; MEAN: 3.73; SD: 3.27; %CV: 87.47. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 1: 1ST INR: 3.1; 2ND INR: 3.1; 3RD INR: 3.0; MEAN: 3.07; SD: 0.06; %CV: 1.88. DONOR 2: 2.5; 2.4; 2.4; 2.43; 0.06; 2.37. SINCE BOTH DONORS ARE BELOW 16% CV, STRIP LOT #235739 MET CRITERIA FOR PRECISION. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (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, INRATIO: >7.5 (SN: (B)(4), TECHNICIAN 1), INRATIO: 2.0 (SN: (B)(4), TECHNICIAN 2), INRATIO: 1.7 (SN: (B)(4), TECHNICIAN 2). PT'S THERAPEUTIC RANGE: 2-3 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235793

    Patients

    Seq Age Sex Outcome Treatment
    1 NI