BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2761557 · Received September 21, 2012

    Report

    Report Number
    2027969-2012-01363
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 THE TIME THE COMPLAINT WAS FILED: DATE: (B)(6) 2012, INRATIO: 1.6, REFERENCE: 4.5, MEAN: 3.05, CONFIDENCE LIMITS: 1.8-4.2. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, THE CRITERIA WAS NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. NO PRODUCT IS EXPECTED TO RETURN. REVIEWED REFERENCE TEST ON REPORTED LOT# K272465. IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON REPORTED LOT# K272465. RESULTS AS FOLLOWS: DONOR (B)(6): INRATIO: 2.1, INRATIO: 2.1, INRATIO: 2.1, REFERENCE: 2.23, %CV: 0.00. DONOR (B)(6): 1.7, 1.8, 1.8, 1.85, 3.27. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. ACCURACY AND PRECISION CRITERIA HAVE BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. ANALYSIS OF CLIENT'S DATA FROM INRATIO AND REFERENCE METHOD REVEALED THAT TEST RESULTS DID NOT MEET ACCURACY CRITERIA. REVIEW OF COMPLAINT REVEALED THAT THE CUSTOMER TOOK LONGER THAN FIFTEEN SECONDS TO APPLY TEST SAMPLE. REVIEWS OF RECENT IN-HOUSE THERAPEUTIC SAMPLE TESTING OF RETAINED STRIPS MET ACCURACY AND PRECISION CRITERIA. (B)(4). THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. 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) 2012, INRATIO: 1.6, LAB: 4.5. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS LESS THAN ONE DAY. PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 K272465

    Patients

    Seq Age Sex Outcome Treatment
    1 NI