BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2003820 · Received February 7, 2011

    Report

    Report Number
    2027969-2011-00260
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 16, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, CUSTOMER WAS HAVING DIFFICULTY USING CAP TUBES AND USED 4 TUBES ON THE SAME FINGER STICK. THIS MAY AFFECT COAGULATION TEST AND CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST = 1.2, 2ND INR = 2.6, MEAN = 1.9, SD = 0.99, %CV: 52.10. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT 234523 FROM A PREVIOUS CASE MET PRECISION CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. CUSTOMER HAVING TROUBLE USE CAP TUBE COULD AFFECT INRATIO TEST RESULT. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TEST RESULT COMPARISON MET PRECISION CRITERIA. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) 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. COMPARATIVE TEST SYSTEM: (B)(4), TYPE OF DONORS: THERAPEUTIC; FUNCTIONAL TEST: NO; VISUAL INSPECTION: YES. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 234523, (B)(4). BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 1.2; DATE: (B)(6) 2011, INRATIO: 2.6. A 1.2 RESULT NOTED TO BE BELOW PT'S TARGET THERAPEUTIC RANGE AND 2.6 NOTED TO BE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234523

    Patients

    Seq Age Sex Outcome Treatment
    1