BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2243705 · Received July 28, 2011

    Report

    Report Number
    2027969-2011-01666
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 28, 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
    FL, 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: 1.1, REFERENCE: 2.7, MEAN: 1.90, CONFIDENCE LIMITS: 1.2-2.3. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO2 AND REFERENCE TEST RESULT COMPARISON 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 STRIP TESTING PERFORMED ON 07/07/2011 REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT# 243104. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ALLOWABLE ACCURACY BIAS (+ OR -1.0). (B)(4). ACTION THRESHOLD (B)(4) WAS REACHED. STRIP LOT # 243104 HAS STRIP CODE Z45BU WITH BRICK LOT # 246544, WHICH WAS ASSIGNED AND PACKAGED INTO TWO STRIP LOTS (243104 AND 251117). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT THRESHOLD OF (B)(4), NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION 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, INRATIO2: 1.1, LAB: 2.7. PT'S THERAPEUTIC RANGE: 2.1-3.5 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