BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3201959 · Received June 27, 2013

    Report

    Report Number
    2027969-2013-00520
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ENTERED THE INCORRECT STRIP CODE PRIOR TO TESTING ON (B)(6) 2013. STRIP CODES ARE LOT SPECIFIC AND ARE DIRECTLY USED TO CALCULATE THE INR AND QC VALUES. USE OF THE INCORRECT CODE CAN RESULT IN INCORRECT RESULTS AND ERROR MESSAGES. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TES WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013, INRATIO METER (INR) 0,8, INRATIO2 METER (INR) 3.2. MEAN + 2.0, SD 1.70, %CV = 84.85. INRATIO METER RESULTS FAILED THE CRITERIA FOR PRECISION, GENERATING A %CV GREATER THAN 20%. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED, BOTH INRATIO AND REFERENCE VALUES WERE OUTSIDE OF THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS WERE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. FURTHER INVESTIGATION WAS REQUIRED. SINCE A LOT NUMBER WAS NOT PROVIDED, AND THE PRODUCT ASSOCIATED WITH THE COMPLAINT IS NOT EXPECTED TO RETURN, PRODUCT SUPPORT WAS UNABLE TO PERFORM FURTHER INVESTIGATION. FURTHER INVESTIGATION WAS NOT POSSIBLE. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY OR PRECISION CRITERIA. CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFORMATION. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. NO CORRECTIVE ACTION AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT CORRELATION RESULTS WHEN COMPARED TO ANOTHER INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO #1: 0.8, INRATIO #2: 3.2. SERIAL AND LOT INFORMATION FROM METERS WERE NOT AVAILABLE. TIME BETWEEN TESTING WAS REPORTED AS A COUPLE OF MINUTES APART. IT WAS REPORTED LATER THIS PATIENT HAD A LAB DRAW AND OBTAINED A RESULT OF 1.5. THE CUSTOMER DID NOT KNOW THE TIME FRAME BETWEEN INRATIO TESTING AND LAB TESTING. THE CUSTOMER ALSO STATED THAT THE WRONG STRIP CODE MAY HAVE BEEN ENTERED INTO THE INRATIO METERS PRIOR TO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291702 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139

    Patients

    Seq Age Sex Outcome Treatment
    1