BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2110484 · Received April 25, 2011

    Report

    Report Number
    2027969-2011-00918
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INR RESULTS PROVIDED BY CUSTOMER WERE PERFORMED MORE THAN THREE HOURS BETWEEN TWO READINGS. SINCE TIME OF TEST EXCEEDED 3 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. DATA ANALYSIS WILL NOT BE PERFORMED AND NO FURTHER INVESTIGATION REQUIRED AT THIS TIME. TESTING CONDUCTED ON LOT 241836 ON 03/16/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 1 = 2.7, 2.8, 2.8 INR; DONOR 2 = 3.1, 3.1, 3.1 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+1.0) OF REFERENCE RESULTS FOR DONOR 1 (2.48 INR) AND DONOR 2 (3.12 INR), RESPECTIVELY. NO FURTHER INVESTIGATION REQUIRED AT THIS TIME. CONCLUSION: THE TIME ELAPSED BETWEEN COMPARISON TESTS EXCEEDS 3 HOURS. THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO CUSTOMER PROVIDED. (B)(4), OVER QA FOR CORRECTIVE ACTION (B)(4). RETAINED STRIP TEST HISTORY: FROM 08/19/2010 TO 04/18/2011, THERE HAVE BEEN 9 THERAPEUTIC AND 3 NORMAL DONOR SAMPLE TESTS PERFORMED. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS OF IN VIVO TESTS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, LAB: 4.3. DATE: (B)(6) 2011, INRATIO: 3.9. CALLED SAID HE HAS BEEN READING HIGH LATELY AND HIS RESULTS HAVE BEEN VERY UNSTABLE. THERAPEUTIC RANGE: 2 - 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1