BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1760141 · Received July 9, 2010

    Report

    Report Number
    2027969-2010-00919
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 21, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ALERE SAN DIEGO, INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO MANUFACTURER'S NAME TO REFLECT REBRANDING OF THE COMPANY. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATLO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: SEE SCANNED TABLE; 5.5 INR WAS EXCLUDED FROM COMPARISON TEST DATA BECAUSE THERE WAS NO CORRESPONDING METER VALUE. ANALYSIS OF THE CUSTOMER'S DATA REVEALED THAT ONE OUT OF FOUR INITIAL INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP WAS TESTED AND RESULT COMPARISONS MET ACCURACY CRITERIA. (SEE PAGE 3 FOR INVESTIGATION) PATIENT'S CONDITION OF ANEMIA AND ON ANTIBIOTICS COULD HAVE CONTRIBUTED TO UNEXPECTED TEST RESULTS. AS OF 08/20/2010, FOUR DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #228758 YIELDING A COMPLAINT RATE OF (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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. SEE SCANNED TABLE. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. ALL THREE REPLICATES FOR BOTH DONORS OF STRIP LOT #228758 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE RESULTS MEET THE ABOVE CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED.

    Description of Event or Problem · 0

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LABS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 2.3, LAB: 5.5; 06/11/2010, INRATIO: 2.3, LAB: 7.5.

    Description of Event or Problem · 0

    ADDITIONAL CORRELATION STUDIES ON 3 MORE PATIENTS WITH LOT # 228758: DATE: 06/18/2010, INRATIO: 2.6, 1.6, 3.6; LAB: 2, 7, 1.6, 3.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478763 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INCORPORATED 100139 228758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NI.