BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2263570 · Received August 19, 2011

    Report

    Report Number
    2027969-2011-01858
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED BECAUSE CUSTOMER USED VENOUS BLOOD FOR TESTING. PER PRODUCT USER GUIDE, "USE ONLY FRESH CAPILLARY BLOOD FOR TESTING." THIS OFF-LABEL USE WOULD CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. CUSTOMER WAS MILKING THE FINGER. PER PRODUCT USER GUIDE - PRECAUTIONS WITH WARNINGS, "DO NOT USE REPETITIVE PRESSURE TO COLLECT THE SAMPLE." SQUEEZING THE FINGERSTICK SITE EXCESSIVELY (MILKING) RELEASE INTERSTITIAL FLUID AND MAY CAUSE INACCURATE RESULTS. CUSTOMER ALSO WIPES THE FIRST DROP AND USES THE SECOND DROP. THIS WOULD ALSO AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR OR ERRORS IN TESTING. RECENT TEST CONDUCTED ON LOT 253026 ON 07/13/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 72 = 4.3, 4.3, 4.4 INR; DONOR 73 = 2.6, 2.1, 2.5 INR. AT LEAST TWO OUT THREE REPLICATES AER WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 72 (3.93 INR) AND DONOR 73 (2.30 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION, NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTIONS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 2.0, LAB: 3.4. DATE: (B)(6) 2011, INRATIO: 1.0, LAB: 1.9. THE NURSE STATED A LAB DRAW WAS TAKEN AND USED FOR THE LAB RESULT FIRST, THEN A DROP OF BLOOD WAS APPLIED TO THE STRIP USING THE SAME SAMPLE. THE NURSE INDICATED SHE HAS A HARD TIME GETTING BLOOD FROM THE PATIENT. WHEN A FINGERSTICK IS PERFORMED SHE DOES MILK HIS FINGER TO GET AN ADEQUATE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1