BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2027340 · Received February 22, 2011

    Report

    Report Number
    2027969-2011-00379
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    December 18, 2010
    Report Date
    February 22, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 5.5, REFERENCE: 7.5, MEAN: 6.5, CONFIDENCE LIMITS: N/A. INRATIO: 3.4, REFERENCE: 2.4, MEAN: 2.90, CONFIDENCE LIMITS: 1.8-4.2. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT ONE OUT OF TWO INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. FOR TEST RESULT COMPARISON BETWEEN INRATIO = 7.5 AND REFERENCE = 1.5 INR, CONFIDENCE LIMITS COULD NOT BE DETERMINED. GENERALLY, INR RESULTS EXCEEDING 5.0 HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POINT-OF-CARE AND LABORATORY BASED PT TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. PER GENERAL DESCRIPTION OF COMPLAINT, PATIENT IS TAKING ALBUTEROL AND ADVAIR. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." AS REVIEWED ON (B)(6) 2011, (B)(6) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243934, 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 SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT #243934. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT #243934 ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0). NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 7.5, LAB: 5.5. DATE: (B)(6) 2011, INRATIO: 3.4, LAB: 2.4. PATIENT'S COUMADIN DOSE WAS ADJUSTED AFTER LAB READING ON (B)(6) 2010. PATIENT'S THERAPEUTIC RANGE: 3.0-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI