BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220024 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01543
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SOMETIMES MILKING THE FINGER. PER PRODUCT USER GUIDE: PRECAUTIONS AND WARNINGS, "DO NOT USE REPETITIVE PRESSURE TO COLLECT THE SAMPLE." SQUEEZING THE FINGERSTICK SITE EXCESSIVELY (MILKING) RELEASES INTERSTITIAL FLUID AND MAY CAUSE INACCURATE RESULTS. PT HAS CUSHINGS SYNDROME AND DOES NOT HAVE A PITUITARY GLAND. PT ALSO HAS DECREASED KIDNEY FUNCTION AND CHRONIC ANEMIA. PT CURRENT HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.1, REFERENCE: 2.5, MEAN: 1.80, CONFIDENCE LIMITS: 1.2 - 2.3. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. RECENT TEST CONDUCTED ON LOT 243104 PM (B)(6) 2011, MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 58 = 2.4, 2.4, 2.4 INR; DONOR 59 = 2.5, 2.6, 2.6 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 58 (2.24 INR) AND DONOR 59 (2.40 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO CUSTOMER PROVIDED. PT'S CONDITION AND SAMPLE TECHNIQUE MAY NOT BE RULED OUT. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (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 SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: (B)(6) 2011, INRATIO: 1.1, LAB: 2.5. PT'S TARGET THERAPEUTIC RANGE IS 2.0 - 3.0. RESULTS DONE SIDE BY SIDE AT A PHYSICIAN'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1