BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1931740 · Received December 7, 2010

    Report

    Report Number
    2027969-2010-02112
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS A-FIB AND IS TAKING LOVAZA, NEXIUM, LASIX, TUMS, ZINC, HYOSCYAMINE, KC1, COSAMIN DS, PROSCAR, TRICOR, NORVASC, ALDACTONE, ENABLEX, PROVIGIL, NORCO, ZEGERID, LEVODOPA, SONATA, MIRALAX, BABY ASPIRIN, CENTRUM CARDIO, BACLOFEN, AND BENADRYL. 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." DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: UNKNOWN, INRATIO: 3.1, REFERENCE: 2.7, MEAN: 2.90, CONFIDENCE LIMITS: 1.8 - 4.2. DATE: (B)(6) 2010, INRATIO: 3.0, REFERENCE: 3.8, MEAN: 3.40, CONFIDENCE LIMITS: 2.0 - 5.0. 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. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. AS REVIEWED ON 12/03/2010, 47 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 234526 YIELDING A COMPLAINT RATE OF 0.039%. 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; CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: LAST WEEK, INRATIO: 3.1, LAB: 2.7 (APPROX 35 MIN. - 1 HOUR LATER). DATE: (B)(6) 2010, INRATIO: 3.8, LAB: 3.0 (APPROX 1 HOUR BETWEEN TESTING). PATIENT DID FIRST LAB COMPARISON LAST WEEK. HE HAD BEEN OFF LOVENOX AND ANTIBIOTICS FOR AT LEAST A WEEK AND A HALF AT THAT TIME. DOCTOR RAISED COUMADIN DOSE YESTERDAY (B)(6) TO KEEP HIS INR CLOSER TO 3 DUE TO HEART VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234526

    Patients

    Seq Age Sex Outcome Treatment
    1