BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2310159 · Received September 28, 2011

    Report

    Report Number
    2027969-2011-02036
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS TAKING ARICEPT, PLAVIX, MULTAQ, ENALAPRIL, MALEATE, OXYBUTYNIN, DONEPEZIL, SANOPINE, TOPROL, SIMVASTATIN, RAPAFLO. 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." PATIENT'S CURRENT MEDICATIONS CANNOT BE RULED OUT AS A CAUSE FOR THE UNEXPECTED INR RESULTS OR ERRORS IN TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST INR = >7.5; 2ND INR = 3.8, MEAN = NA; SD = NA; %CV = NA. PER GENERAL DESCRIPTION, CUSTOMER PRODUCED GREATER THAN 7.5 INR. INRATIO METER MEASURES INR RANGE FROM 0.7-7.5 INR. THIS UNEXPECTED RESULTS ARE CAUSED BY THE FOLLOWING: A HEMATOCRIT THAT IS HIGHER OR LOWER THAN THE VALIDATED OPERATING RANGE OF THE INRATIO SYSTEM CAN CAUSE INACCURATE RESULT. LUPUS OR ANTIPHOSPHOLIPID ANTIBODY SYNDROME (APS) MAY FALSELY PROLONG THE INR VALUE. CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS THAT CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. LIVER DISEASE, CONGESTIVE HEART FAILURE, THYROID DYSFUNCTION, AND OTHER DISEASES OR CONDITIONS CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. CHANGES IN DIET, LIFESTYLE, OR TAKING NUTRITIONAL SUPPLEMENTS SUCH AS GINKGO BILOBA CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. RECENT TEST CONDUCTED ON LOT 243396 ON 08/23/2011 MET ACCURACY AND PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 92 = 3.2, 2.6, 3.0 INR; DONOR 93 = 2.0, 1.9, 2.0 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+/- 1.0) OF REFERENCE RESULTS FOR DONOR 92 (3.02 INR) AND DONOR 93 (2.14) INR, RESPECTIVELY. IN-HOUSE TEST RESULTS HAVE 10.41% AND 2.94%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. PATIENT'S MEDICATIONS MAY HAVE INTERACTION WITH COUMADIN. PATIENT'S COUMADIN INFORMATION WAS NOT AVAILABLE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION CUSTOMER PROVIDED. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET PRECISION AND 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

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL = >7.5, REPEAT = 3.8. THERAPEUTIC RANGE: 2.0-3.0. TECHNICAL SERVICE PROVIDED TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243396

    Patients

    Seq Age Sex Outcome Treatment
    1