BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1935161 · Received December 6, 2010

    Report

    Report Number
    2027969-2010-02119
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, CUSTOMER WAS MILKING THE FINGER. MILKING THE FINGER MAY CAUSE CONTAMINATION WITH INTERSTITIAL FLUIDS AND MAY LEAD TO INACCURATE 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) 2010, INRATIO METER = 1.5 INR, REFERENCE = 2.6 INR, MEAN = 2.05, CONFIDENCE LIMITS = 1.3 - 2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION IS REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. IMPROPER TESTING TECHNIQUES WHICH CAUSED INACCURATE RESULT WERE IDENTIFIED IN TROUBLE SHOOT. AS REVIEWED ON 12/03/2010, 55 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #234130 YIELDING A COMPLAINT RATE OF 0.049%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), 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

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 1.5, LAB: 2.6. CLIENT HAD A DISCREPANT RESULT THIS WEEK. HE RAN HIS INRATIO AT HOME 1.5 AND THEN WENT INTO HOSPITAL FOR PROCEDURE AND LAB GOT 2.6 BEFORE PROCEDURE. CLIENT DID NOT EAT OR DRINK ANYTHING IN BETWEEN TESTS. PER TECHNICAL SUPPORT, THE CUSTOMER WAS TAKING TOO LONG TO GET THE SAMPLE AND WAS 'MILKING' HIS FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1