BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5157823 · Received October 16, 2015

    Report

    Report Number
    2027969-2015-00856
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 20, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    CORRECTION: IN THE MANUFACTURER'S NARRATIVE IN FOLLOW UP #1, THE LOT NUMBER IN THE REPORT, K360380, WAS INCORRECT. THE LOT NUMBER THAT HAD IN-HOUSE TESTING REVIEWED WAS 361976. THE CORRECT VERBIAGE FOR THIS SECTION SHOULD BE AS FOLLOWS: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. AS A RESULT, IN-HOUSE INVESTIGATION TESTING WAS PERFORMED WITH RETAINS OF THE REPORTED STRIP LOT. IT WAS DETERMINED THAT A DISCREPANT RESULT OBSERVED IN-HOUSE WAS CAUSED BY AN IMPEDANCE CURVE WITH A WEAK SLOPE CHANGE. DISCREPANT RESULTS CAUSED BY WEAK SLOPE CHANGES ARE RELATED TO THE SOFTWARE PRESENT IN THE METER; THIS ISSUE WAS ADDRESSED IN CAPA-(B)(4). ALTHOUGH DISCREPANT RESULTS WERE OBSERVED DURING IN-HOUSE TESTING, AN ANALYSIS OF ALL IN-HOUSE TESTING RESULTS FOR THE REPORTED LOT DETERMINED THAT THE LOT MEETS EXPECTATIONS. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR THE REPORTED STRIP LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    'DISABILITY OR PERMANENT DAMAGE' WAS INADVERTENTLY MARKED. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS CASE. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. AS A RESULT, IN-HOUSE RETAIN TESTING WAS PERFORMED WITH RETAINS OF STRIP LOT 361976. DURING IN-HOUSE INVESTIGATION, AN IMPEDANCE CURVE WITH A WEAK SLOPE CHANGE WAS OBSERVED. DISCREPANT RESULTS CAUSED BY WEAK SLOPE CHANGES ARE RELATED TO THE SOFTWARE PRESENT IN THE METER; THIS ISSUE WAS ADDRESSED IN CAPA-(B)(4). ALTHOUGH DISCREPANT RESULTS WERE OBSERVED DURING IN-HOUSE TESTING, AN ANALYSIS OF ALL IN-HOUSE TESTING RESULTS FOR LOT K360380 DETERMINED THAT THE LOT MEETS EXPECTATIONS. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR THE REPORTED STRIP LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN INRATIO INR RESULTS. THE RESULTS OCCURRED ON THE SAME DAY AS FOLLOWS: INRATIO INR=3.9, 4.5 AND 1.2 - WITHIN SEVERAL MINUTES. THE VENOUS BLOOD WAS TAKEN FROM THE SAME SYRINGE. SEVERAL MINUTES LATER, THE CUSTOMER TESTED TWO MORE TIMES WITH A NEW SAMPLE OF VENOUS BLOOD AND OBTAINED THE FOLLOWING RESULTS: INRATIO INR=1.3 AND 1.2. THE PATIENT'S THERAPEUTIC RANGE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687898 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 361976

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability