BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIPS

    MDR report key: 3902771 · Received May 9, 2014

    Report

    Report Number
    2027969-2014-00424
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Removal / Correction Number
    2027969-04/16/14-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE PT WAS REPORTED AS USING HEPARIN. LIMITATIONS IN PACKAGE INSERT (PI), "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." ADDITIONALLY THE CUSTOMER UTILIZED VENOUS BLOOD SAMPLE DURING SAMPLE APPLICATION. THIS CONSTITUTES OFF-LABEL USE AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. THE MFG RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE LAB INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO2 INR: 1.6. LAB INR: 2.8. THERAPEUTIC RANGE: UNK. THE TIME BETWEEN TESTING WAS UNK. REPORTEDLY THE PT WAS ON LOVENOX AND A VENOUS SAMPLE WAS USED FOR THE INRATIO2 INR. THE CUSTOMER WAS UNWILLING TO TROUBLESHOOT SAMPLING TECHNIQUE. CUSTOMER WAS PERFORMING A CORRELATION STUDY BETWEEN THE INRATIO2 AND THE LAB. ALL OTHER TESTS (UNK TOTAL AMOUNT OF TEST) WERE IN A RANGE THAT WAS ACCEPTABLE TO THE FACILITY. THERE WAS NO MED INTERVENTION ON BEHALF OF THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281635 INRATIO2 PT/INR PROFESSIONAL TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 333362

    Patients

    Seq Age Sex Outcome Treatment
    1 ADDITIONAL UNSPECIFIED MEDICATIONS| FUROSEMIDE,| COUMADIN,| LOVENOX,| INRATIO MONITOR SN UNK,