BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2724832 · Received August 30, 2012

    Report

    Report Number
    2027969-2012-01262
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 30, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S)PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2012; INRATIO: 1.8; REF: 3.2; MEAN: 2.5; CONFIDENCE LIMITS: 1.6-3.4; RESULT: PASS. DATE: (B)(6) 2012; INRATIO: 4.2; REF: 2.1; MEAN: 3.15; CONFIDENCE LIMITS: 1.9-4.6; RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 282855 ON (B)(6) 2012. RESULTS AS FOLLOWS: DONOR 216; INRATIO: 3.8; INRATIO: 4.2, INRATIO: 4.1; REF: 3.74; BIAS THRESHOLD: 2.74-4.74; %CV: 5.16. DONOR 202; INRATIO: 2.9; INRATIO: 2.9, INRATIO: 2.9; REF: 2.77; BIAS THRESHOLD: 1.77 - 3.77; %CV: 0.00. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. CONCLUSION: ANALYSIS OF CLIENT'S DATA FROM INRATIO AND REFERENCE METHOD REVEALED THAT TEST RESULTS WITHIN THE CONFIDENCE LIMITS. ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT IS EXPECTED TO BE RETURNED; REVIEW OF RECENT IN-HOUSE THERAPEUTIC SAMPLE TESTING FOUND RETAIN STRIPS MET ACCURACY AND PRECISION CRITERIA. (B)(4). 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 REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012; INRATIO2: 1.8; DOCTOR'S POC: 3.2; LAB: ---. DATE: (B)(6) 2012; INRATIO2: 4.2; DOCTOR'S POC: ---; LAB: 2.1. NO EXACT DATE PROVIDED. CUSTOMER STATED RESULTS WERE FROM ABOUT TWO WEEKS AGO. NO THERAPEUTIC RANGE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 282855

    Patients

    Seq Age Sex Outcome Treatment
    1