BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2190058 · Received June 29, 2011

    Report

    Report Number
    2027969-2011-01438
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAS A THYROID DISORDER. PT CURRENT HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. PT NOTES SOMETIMES IT TAKES A LONG TIME TO APPLY BLOOD TO TEST STRIP AFTER FINGER STICK IS PERFORMED. THIS MAY AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR OR ERRORS IN TESTING. BLOOD SHOULD BE APPLIED WITHIN 15 SECONDS OF FINGER STICK. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO METER: 4.1, REFERENCE: 3.2, MEAN: 3.65, CONFIDENCE LIMITS: 2.2 - 5.3. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS 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. INR OF 4.5 WAS EXCLUDED FROM DATA ANALYSIS BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. 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. RECENT TEST CONDUCTED ON LOT #234527 ON 06/13/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 52: 1.7, 1.7, 1.7 INR; DONOR 53: 2.6, 2.5, 2.5 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 52 (1.70 INR) AND DONOR 53 (2.53 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. 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. NO PRODUCT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. RETAIN STRIP TESTING RESULTS MET ACCURACY CRITERIA. PT'S MEDICAL CONDITION AND MEDICATIONS AS A CAUSE OF THE UNEXPECTED RESULTS CANNOT BE RULED OUT. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. (B)(4). TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE REQUIREMENTS WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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: 4.1, LAB: 3.2, RE-TEST: 4.5. LAB VALUE WAS OBTAINED TWO HOURS AFTER METER TESTING. RE-TEST WAS DONE 6 HOURS AFTER LAB TESTING. PT DISCONTINUED AMOXICILLIN ONE WEEK AGO AND HAS BEEN TREATED WITH LMWH THE PAST FEW DAYS. CUSTOMER STATED IT SOMETIMES TAKES HER A LONG TIME TO APPLY THE SAMPLE AFTER POKING HER FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234527

    Patients

    Seq Age Sex Outcome Treatment
    1