BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2190057 · Received June 29, 2011

    Report

    Report Number
    2027969-2011-01436
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO METER: 1.3 INR, REFERENCE: 2.3 INR, MEAN: 1.80, CONFIDENCE LIMITS: 1.2-2.3. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. RECENT TEST CONDUCTED ON LOT 235737 ON (B)(6) 2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 52: 1.8, 1.8, 1.9 INR; DONOR 53: 2.5, 2.2, 2.3 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS OF REFERENCE RESULTS FOR DONOR 52 (1.70 INR) AND DONOR 53 (2.53 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935 WHICH BRICK LOT NUMBER VD7HT WAS ASSIGNED AND PACKAGED INTO TWO STRIP LOTS (234590 AND 235737). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 1.3, LAB: 2.3. CUSTOMER'S THERAPEUTIC RANGE IS BETWEEN 2.5 AND 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1