BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5848773 · Received August 4, 2016

    Report

    Report Number
    2027969-2016-00549
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Report Date
    July 19, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K380736 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION CANNOT BE PURSUED BECAUSE THERE IS NO LOT NUMBER AND PRODUCT WAS NOT RETURNED. NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL INVESTIGATION CONCLUSION WAS AS FOLLOWS: INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K380736 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION CANNOT BE PURSUED BECAUSE THERE IS NO LOT NUMBER AND PRODUCT WAS NOT RETURNED. NO CORRECTIVE ACTION IS REQUIRED. THE LOT NUMBER OF THE PRODUCT WAS PROVIDED. THE CORRECTED INVESTIGATION CONCLUSION IS AS FOLLOWS: INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K380736 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE FOLLOWING RESULTS FOR A PATIENT OCCURRING TWO TO FOUR WEEKS PRIOR TO THE DATE OF THIS REPORT: INRATIO INR RESULT= 2.7, ONE DAY LATER INRATIO INR RESULT= 3.6, LABORATORY INR RESULT= 1.7, LABORATORY INR RESULT= 3.2. THERAPEUTIC RANGE: 2.0 - 2.5. INRATIO INR TESTS CONDUCTED ONE DAY APART. PHYSICIAN UNABLE TO SPECIFY TIMING OF LABORATORY INR TESTS IN RELATION TO INRATIO INR TESTS. PHYSICIAN UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498965 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K380736

    Patients

    Seq Age Sex Outcome Treatment
    1