BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4071888 · Received August 12, 2014

    Report

    Report Number
    2027969-2014-00744
    Event Type
    Malfunction
    Date Received
    August 12, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. 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. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT. THIS COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. 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 INFORMATION 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 LOW INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR: 1.2 ((B)(4)), 2.0 ((B)(4)). THE TIME BETWEEN TESTING WAS LESS THAN 10 MINUTES. REPORTEDLY "MILKING" FINGER AFTER FINGER STICK. THERAPEUTIC RANGE 2.0 - 3.0 FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479034 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 343292

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG 50 UNITS| LANTUS 44 UNITS| ESTRADIOL 1MG| COLACE 200MG (TWICE A DAY)| INRATIO MONITOR: (B)(4)| COUMADIN 3MG| VITAMIN C (DOSAGE NOT PROVIDED)| PROGESTERONE 200MG| CALCITROL 2.5MG| DIGOXIN 0.125MG| INRATIO MONITOR: (B)(4)