BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2010225 · Received February 11, 2011

    Report

    Report Number
    2027969-2011-00303
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 10, 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
    GA, 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: 1.5, REFERENCE: 2.5, MEAN: 2.00, CONFIDENCE LIMITS: 1.3-2.7. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.5, 2ND INR: 1.4, MEAN: 1.45, SD: 0.07, %CV: 4.88. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO VERSUS REFERENCE AND REPEATED INRATIO TEST RESULT COMPARISONS DID MEET ACCURACY AND PRECISION CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. (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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.5, LAB: 2.5. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.5 (STRIP LOT #243934), 1.4 (STRIP LOT #234523). PATIENT HAS BEEN HAVING DISCREPANT ISSUE FOR ABOUT 3 TO 4 WEEKS. HE HAS BEEN TESTING ON THE METER SINCE (B)(6) 2010.

    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