BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATION PT/INR TEST STRIPS

    MDR report key: 3921926 · Received May 28, 2014

    Report

    Report Number
    2027969-2014-00496
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THIS COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: (B)(4). TIME BETWEEN TESTS ON (B)(6) 2014 AND (B)(6) 2014: 10 HRS. RESULTS FROM (B)(6) 2014 WERE TAKEN 5 MINUTES APART. RESULTS FROM (B)(6) 2014 WERE TAKEN 30 MINUTES APART. THERAPEUTIC RANGE: 2.5-3.5. PT VISITED THE ER ON (B)(6) 2014 DUE TO HIGH BLOOD PRESSURE AND NOT FEELING WELL. UPON ADMITTANCE TO THE ER AT 10:30PM, LAB=4.37. NO CHANGES WERE MADE TO COUMADIN DOSE, AND NO VITAMIN K WAS GIVEN. PT WAS DISCHARGED THE SAME NIGHT. PHYSICIAN BELIEVES PT MAY BE COMING DOWN WITH A COLD AND NEEDS MORE SLEEP. PT ALSO WENT TO THE HOSPITAL ON (B)(6) 2014 FOR A CARDIAC ABLATION PROCEDURE. PT WENT HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314860 INRATION PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 332830

    Patients

    Seq Age Sex Outcome Treatment
    1 LISINOPRIL| AMBIEN (STARTED 1-1.5 WEEKS AGO)| AMIODARONE| VITAMIN B6| ASPIRIN| PEPCID AC| STOOL SOFTNER| DIGOXIN| BENEFIBER| BRILINTA| CARVEDIOLOL| INRATIO MONITOR SN: (B)(4)| COUMADIN| MIRAPEX| FUROSEMIDE| LIPITOR| MULTIVITAMIN