BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2222052 · Received August 17, 2011

    Report

    Report Number
    2027969-2011-01837
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 17, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.1; 2ND INR: 3.3; MEAN: 2.20; SD: 1.56; %CV: 70.71. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION 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 STRIP TESTING PERFORMED ON 07/0/2011 REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT #243104: DONOR 74: 1ST INR: 2.1; 2ND INR: 1.9; 3RD INR: 2.0; MEAN: 2.00; %CV: 5.00. DONOR 75 - 1ST INR: 3.6; 2ND INR: 3.7; 3RD INR: 3.7; MEAN: 3.67; %CV: 1.57. %CV FOR BOTH DONORS ARE LESS THAN 16% AND MEET THE CRITERIA FOR PRECISION. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). ACTION THRESHOLD (B)(4) WAS REACHED. STRIP LOT IN COMPLAINT HAS STRIP LOT CODE Z45BU WITH BRICK LOT #246544 WHICH WAS SPLIT INTO TWO DIFFERENT LOTS (243104 AND 251117). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL ACTION THRESHOLD OF (B)(4), NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 1.1, 3.3. PT'S THERAPEUTIC RANGE IS 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 NI