BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3853706 · Received April 10, 2014

    Report

    Report Number
    2027969-2014-00317
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE CUSTOMER REPORTED A PRECISION ISSUE DURING TESTING ON THEIR INRATIO METER. 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 RETAIN TESTING WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. ADDITIONALLY, THE CUSTOMER USED MICROSAFE TUBES DURING SAMPLE COLLECTION AND SAMPLE APPLICATION. THE USE OF MICROSAFE TUBES HAS NOT BEEN VALIDATED FOR THE USE ON THE INRATIO SYSTEM AND IS CONSIDERED OFF-LABEL USE. THE CUSTOMER'S OFF-LABEL USE MAY HAVE CONTRIBUTED TO 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 PURSED 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 INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR: 1.2 AND 2.8. THERAPEUTIC RANGE: UNKNOWN. THE TIME BETWEEN TESTING WAS WITHIN FIVE (5) MINUTES. REPORTEDLY, THE CUSTOMER WAS USING MICROSAFE CAPILLARY TUBES DURING SAMPLE COLLECTION AND APPLICATION. ADDITIONALLY, MULTIPLE FINGER STICKS WERE PERFORMED ON THE SAME FINGER. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217505 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 99008G2 330238

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO METER, SN: UNKNOWN