BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000482 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00233
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    LZG
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, CUSTOMER IS TAKING ANTIBIOTICS AND STARTED TAKING PREDNISONE. 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." NO DATA ANALYSIS WAS PERFORMED BECAUSE TESTING WAS DONE ON SEPARATE DAYS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PREVIOUS INVESTIGATION OF STRIP LOT 243934 FROM A PREVIOUS CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), NO FURTHER ACTION IS REQUIRED AT THIS TIME. STRIP INVESTIGATION WAS PERFORMED ON LOT 243934. GREATER THAN +/- 1.0 BIAS IS OBTAINED ON RETURNED UNIT. TWO MORE DONORS WILL BE TESTED TO ELIMINATE THE POSSIBILITY THAT THE FAILURE IS DUE TO DONOR SPECIFIC EFFECT. ADD'L INVESTIGATIONS ARE PERFORMED ON (B)(6) 2011. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 243934 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. 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, LAB: 3.1. (B)(6) 2011, INRATIO: 1.4. RESULTS DONE WITHIN MINUTES OF EACH OTHER. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. CUSTOMER STATES THAT HE OBTAINED THE SAME RESULT WITH THE METER LAST WEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1