BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2117956 · Received April 29, 2011

    Report

    Report Number
    2027969-2011-00966
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NES ERROR OCCURRED WHEN THERE WAS NOT ENOUGH SAMPLE APPLIED TO THE TEST STRIPS TO FILL THE TEST AREA, AND/OR STRIP CHANNEL WAS BLOCKED. ALL INR RESULTS PROVIDED BY CUSTOMER ARE PERFORMED MORE THAN THREE HOURS BETWEEN TWO READINGS. SINCE TIME OF TEST 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. DATA ANALYSIS WILL NOT BE PERFORMED AND NO FURTHER INVESTIGATION WILL BE PURSUED. RECENT TEST CONDUCTED ON LOT 241836 ON 3/16/2011 MET BOTH ACCURACY AND PRECISION 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. IN-HOUSE PRECISION TEST RESULTS HAVE 2.09% AND 0%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. AS REVIEWED ON 4/29/2011, THE 91 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #241836 YIELDING A COMPLAINT RATE OF 0.097%. ACTION THRESHOLD (>0.07%) HAS BEEN REACHED. SINCE STRIP LOT RELEASED, FOUR IN-HOUSE THERAPEUTIC SAMPLE TESTS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 1.3 AND 1.9. PT TESTED A TOTAL OF 3 TIMES AND WAS ABLE TO GET A RESULT, INR = 1.3, ON THIRD ATTEMPT. PT GOT NES ERROR TWICE BECAUSE SHE WASN'T ABLE TO GET ENOUGH SAMPLE ONTO STRIP; SHE STATED THAT THE BLOOD DIDN'T GO UP THE CHANNELS. DOCTOR WANTS HER TO BE AROUND 2.1. LAST WEEK HER INR = 1.9. HER INR RESULTS ARE NORMALLY STABLE.

    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