BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2854298 · Received November 28, 2012

    Report

    Report Number
    2027969-2012-01645
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2012, INRATIO: 3.0, REFERENCE: 6.3, MEAN: 4.65, CONFIDENCE LIMITS: 2.6 - 6.9, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. USER REPORTED TESTING WITH METER ON A NON-FLAT SURFACE. PER PRODUCT USER GUIDE - PRECAUTIONS AND WARNINGS, "TEST WITH THE METER ON A LEVEL SURFACE." USER ALSO REPORTED ADDING MORE THAN ONE DROP OF SAMPLE TO TEST STRIP. DOUBLE DROPPING (ADDING TWO DROPS TO ONE STRIP) IS A KNOWN CAUSE FOR PRE-ANALYTICAL ERRORS IN FINGERSTICK SAMPLE COLLECTION. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 284355 ON (B)(4) 2012. RESULTS AS FOLLOWS: DONOR 1: INRATIO: 2.4, 3.1, 3.2, REF: 3.30, BIAS THRESHOLD: 2.30 - 4.30, %CV: 15.03. DONOR 2: INRATIO: 4.2, 4.5, 5.3, REF: 4.12, BIAS THRESHOLD: 3.12 - 5.12, %CV: 12.18. THE MINIMUM 2 OUT OF 3 REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. RESULTS FROM RETAIN STRIP TESTING ON IN-HOUSE METERS MET BOTH ACCURACY AND PRECISION CRITERIA. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE RESULT DIFFERENCE. FIVE (5) DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT 284355 YIELDING A COMPLAINT RATE OF 0.004%. BECAUSE THIS OCCURRENCE RATE IS BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF 0.07%, NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE AND LOT NUMBER 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: 3.0, LAB: 6.3. THERAPEUTIC RANGE 2.5-3.5. TEST NOT PERFORMED ON A LEVEL SURFACE- METER ON A SOFT TOP STOOL DURING TESTING; FIRST DROP NOT ADDED AND MULTIPLE DROPS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 284355

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN