BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2022501 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00338
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 9, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS BECAUSE TIME BETWEEN TESTING EXCEEDS THREE HOURS AND IMPROPER TECHNIQUE WAS USED. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PER CASE DETAILS, PATIENT WAS TESTING THE SAME FINGER. CUSTOMER HAS BEEN IN AND OUT OF THE HOSPITAL AND WAS TAKING ANTIBIOTICS, AS WELL AS GLIPIZIDE, LISINOPRIL, FUROSEMIDE, LIPITOR, ALLOPURINOL, AND ADVAIR. CUSTOMER JUST STARTED CARVEDILOL AND ALBUTEROL. 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." PREVIOUS INVESTIGATION OF STRIP LOT #234523 FROM ANOTHER CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND SYSMEX INRS ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT #234523 ARE WITHIN THE ALLOWABLE BIAS (+ OR -1.0). NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. CONCLUSION: (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. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.1. DATE: (B)(6) 2011, LAB: 4.3. PATIENT, A SELF TESTER, ALWAYS TESTS HIS GLUCOSE FIRST, THEN STICKS SAME FINGER WITH 23 G LANCET TO GET INRATIO SAMPLE. PATIENT REPORTS SOMETIMES HAVING TROUBLE GETTING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234523

    Patients

    Seq Age Sex Outcome Treatment
    1