BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2251716 · Received August 31, 2011

    Report

    Report Number
    2027969-2011-01908
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 31, 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: 7.2, REFERENCE: 2.0, MEAN: 4.60, CONFIDENCE LIMITS: 2.5-6.5. 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 STRIPS WERE TESTED ON (B)(6) 2011 AND REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. (SEE BELOW). INVESTIGATION RESULTS FOR RETAINED STRIP LOT NUMBER 251117: AT LEASE TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) FOR ACCURACY CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. AS REVIEWED ON (B)(6) 2011, SEVENTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT NUMBER 251117, YIELDING A COMPLAINT RATE OF 0.006 PERCENT. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD MONITORED BY QA FOR CORRECTIVE ACTION (>0.07 PERCENT), 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 DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 7.2, LAB: 2.0. PATIENT'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. 100139 251117

    Patients

    Seq Age Sex Outcome Treatment
    1 NI