BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3221802 · Received July 8, 2013

    Report

    Report Number
    2027969-2013-00551
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER ADDED MULTIPLE DROPS OF BLOOD DURING SAMPLE APPLICATION. ONCE BLOOD IS ADDED TO THE SAMPLE WELL, IT WILL TRAVEL DOWN THE STRIP CHANNELS AND WILL INITIATE TESTING. ADDING MULTIPLE DROPS OF BLOOD WILL DISRUPT THE INITIAL TESTING REACTION AND MAY CONTRIBUTE TO UNEXPECTED INR RESULTS OR TESTING ERRORS. THE CUSTOMER'S IMPROPER TECHNIQUE CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE OBSERVED INR VALUE. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME. COMPLAINT WAS FILLED: DATE: (B)(6) 2013, INRATIO: 4.8, REFERENCE: 9.6, MEAN: 7.2, CONFIDENCE LIMITS: NA. PRODUCT SUPPORT WAS UNABLE TO CALCULATE THE CONFIDENCE LIMITS OF THE INRATIO METER AND COMPARATIVE SYSTEM INR RESULTS. SINCE THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2, THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF DOCUMENTED VARIABILITY FOR INR TESTING. ADD'L INFO WAS REQUIRED. IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON RETURNED STRIPS LOT # 305772 ON (B)(6) 2013. RESULTS AS FOLLOWS: DONOR A) 223, INRATIO: 3.0, 3.0, 2.9, REFERENCE: 2.60, BIAS THRESHOLD: 1.60 - 3.60, %CV: 1.95; B) 232, 1.6, 1.9, 1.9, 1.70, 1.20 - 2.20, 9.62. RETENTION PRODUCTS PERFORMED AS EXPECTED. ALL REPLICATES WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY AND YIELDED A %CV OF LESS THAN 16%, PASSING THE PRECISION CRITERIA. NO FURTHER INVESTIGATION WAS REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED, THEREFORE, RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. THE RETAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. ONE (1) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #305772, YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4)); NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECTED TO TRACKING AND TRENDING. THERE IS NO CORRECTIVE ACTION REQUIRED AT THIS TIME, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED FOUR DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LAB INR RESULT. THE RESULTS FOR ONLY ONE PT WAS PROVIDED AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 4.8, LAB INR: 9.6. THE TIME BETWEEN WAS THIRTY MINUTES. REPORTEDLY, MULTIPLE DROPS OF BLOOD WAS ADDED TO THE TEST STRIP. THERAPEUTIC RANGE WAS NOT PROVIDED FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308807 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 305772

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN