BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2110468 · Received April 25, 2011

    Report

    Report Number
    2027969-2011-00914
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 25, 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
    FL, 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 TIME COMPLAINT WAS FILED: INRATIO: 4.1, REFERENCE: 3.5, MEAN: 3.80, CONFIDENCE LIMITS: 2.2 - 5.3; 6.1, 3.5, 4.80, 2.6 - 6.9. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 4.1, 2ND INR: 6.1, MEAN: 5.10, SD: 1.41, %CV: 27.23. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS DID MEET ACCURACY CRITERIA. HOWEVER, REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. 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: 1ST INR: 2.7, 2ND INR: 2.7, 3RD INR: 2.4, MEAN: 2.60, SD: 0.17, %CV: 6.66; DONOR 2: 1ST INR: 3.0, 2ND INR: 3.0, 3RD INR: 3.0, MEAN: 3.00, SD: 0.0, %CV: 0.00. SINCE %CV ARE LESS THAN 16%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER INVESTIGATION REQUIRED. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. FROM 8/19/2010 TO 4/18/2011, 9 THERAPEUTIC AND 3 NORMAL DONOR SAMPLE TESTS HAVE BEEN PERFORMED. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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 DR'S METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.1, DR'S METER: 3.5; INRATIO: 6.1; 3.5. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.1, 6.1. THERAPEUTIC RANGE: 2.5 - 3.5 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