BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2265108 · Received August 18, 2011

    Report

    Report Number
    2027969-2011-01852
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO2 TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO2: 1.0, REFERENCE: 2.8, MEAN: 1.90, CONFIDENCE LIMITS: 1.3-2.7. INRATIO2: 1.0, REFERENCE: 1.7, MEAN: 1.35, CONFIDENCE LIMITS: 1.0-1.5. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO2 AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY 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 STRIPS WERE TESTED ON 07/20/2011 AND REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ALLOWABLE BIAS (+ OR -1.0) FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). ACTION THRESHOLD (B)(4) WAS REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE Z45BU WITH BRICK LOT #246544, WHICH WAS SPLIT INTO TWO DIFFERENT LOTS (243104 AND 251117). (B)(4), WHICH IS BELOW THE TOTAL ACTION THRESHOLD OF (B)(4). NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (PT'S DAUGHTER) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 1.0, LAB: 2.8. DATE: (B)(6) 2011, INRATIO2: 1.0, LAB: 1.7. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 NI