BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    MDR report key: 3972853 · Received April 28, 2014

    Report

    Report Number
    2027969-2014-00374
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 3, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. MANUFACTURING RECORD REVIEW WAS NOT PERFORMED. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADD'L INFO. THE CUSTOMER UTILIZED CAPILLARY TUBES DURING SAMPLE COLLECTION. THE USE OF CAPILLARY TUBES IS NOT VALIDATED FOR THE USE ON THE ALERE INRATIO2 PT/INR PROFESSIONAL TEST STRIP. ADDITIONALLY, IMPROPER USE OF THE MONITOR WAS IDENTIFIED IN THE COMPLAINT. THESE 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. 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 LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO2 INR: 1.6, LABORATORY INR: 2.2, THERAPEUTIC RANGE: UNK. THE EXACT TIME BETWEEN TESTING IS UNK, HOWEVER, BOTH TESTS PERFORMED ON THE SAME DAY. REPORTEDLY, THE MONITOR WAS NOT IN THE CORRECT MODE WHEN FINGER STICK WAS PERFORMED. IN ADDITION, THE CUSTOMER WAS USING CAPILLARY TUBES DURING THE SAMPLE COLLECTION. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WA SNO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253614 INRATIO2 PT/INR PROFESSIONAL TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN: UNK| POTASSIUM| WARFARIN| DILTIAZEM| LASIX