BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 4041122 · Received August 14, 2014

    Report

    Report Number
    2027969-2014-00755
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. 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 PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECS 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 ALLEGING RECEIVING DISCREPANT INRATIO VALUES. ONE LOT, THREE METERS, ONE PT, ONE TECH; (B)(6) 2014, METER 1 (SN: (B)(4)) INRATIO INR=4.7; METER 2 (SN: (B)(4)) INRATIO INR=2.4; METER 3 (SN: (B)(4)) INRATIO INR=1.5; LAB INR=1.7. FEW MINUTES BETWEEN EACH TEST, ALL PERFORMED WITHIN A HALF HOUR. PT'S THERAPEUTIC RANGE 2-3. NO REPORTED ADVERSE PT SEQUELA. IT WAS NOTED ON (B)(6) THAT THE TECH HAD BEEN OBSERVED TO NOT ALLOW ALCOHOL TO DRY COMPLETELY BEFORE TESTING. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488164 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 345309

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR: SN (B)(4)| ASPIRIN DOSAGE UNK| COUMADIN DOSAGE UNK| INRATIO MONITOR: SN (B)(4)| INRATIO MONITOR: SN (B)(4)