BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1899099 · Received November 9, 2010

    Report

    Report Number
    2027969-2010-01910
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS LYME DISEASE AND IS TAKING ANTIBIOTICS. PATIENT CURRENT MEDICATION AND HEALTH STATUS MAY AFFECT COAGULATION TEST. THIS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. DATA ANALYSIS COULD NOT BE CALCULATED SINCE TIME BETWEEN TESTS EXCEEDS THREE HOURS. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PREVIOUS INVESTIGATION OF STRIP LOT #233708 FROM ANOTHER CASE MET ACCURACY CRITERIA. CONCLUSION: NO REFERENCE OR REPEATED INRATIO TEST RESULT WAS AVAILABLE FROM CUSTOMER. PATIENT TAKING ANTIBIOTICS MIGHT BE A FACTOR IN UNEXPECTED INR TEST RESULT. COMPLAINT DID NOT CONTAIN SUFFICIENT INFORMATION FOR ROOT CAUSE ANALYSIS. AS REVIEWED ON 11/07/2010, AT 74 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.055%. 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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.8. (B)(6) 2010, 1.8. (B)(6) 2010, 2.0. (B)(6) 2010, LAB: 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1