BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1985090 · Received February 3, 2011

    Report

    Report Number
    2027969-2011-00252
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON CUSTOMER¿S RESULTS DUE TO IMPROPER TESTING TECHNIQUE. PER GENERAL DESCRIPTION OF COMPLAINT, PT WAS TESTING ON THE SAME FINGER. PER PRODUCT USER GUIDE, RE-STICKING THE SAME SITE MAY CAUSE PRE-ANALYTICAL ERRORS IN FINGERSTICK AND MAY LEAD TO UNEXPECTED INR RESULTS OR ERRORS IN TESTING. A NEW FINGER SITE SHOULD BE USED WHEN RE-TESTING ON THE INRATIO METER. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 1: RETURN1: 1.5; IN-HOUSE2: 1.4; IN-HOUSE3: 1.6; MEAN: 1.50; SD: 0.10; %CV: 6.67. DONOR 2: RETURN1: 2.0; IN-HOUSE2: 2.1; IN-HOUSE3: 2.0; MEAN: 2.03; SD: 0.06; %CV: 2.84. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE OF STRIP LOT 243934, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 6.67% AND 2.84%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. AS OF 2/1/2011, SEVENTY DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243934, YIELDING A COMPLAINT RATE OF 0.052%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(4) 2011; INRATIO: 1.4, 2.8. PT¿S THERAPEUTIC RANGE: 2-3 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI