BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2042054 · Received March 25, 2011

    Report

    Report Number
    2027969-2011-00617
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 1.0, REFERENCE: 2.5, MEAN: 1.75, CONFIDENCE LIMITS: 1.2-2.3. INRATIO: 2.0, REFERENCE: 2.5, MEAN: 2.25, CONFIDENCE LIMITS: 1.4-3.1. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.0, 2ND INR: 2.0, MEAN: 1.50, SD: 0.71, %CV: 47.14. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT ONE OUT OF TWO INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. IN ADDITION, REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT RESULT COMPARISONS MET ACCURACY AND PRECISION CRITERIA. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. (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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION DATA FROM A PREVIOUS CASE ON STRIP LOT #243932: ACCURACY TESTING: DONOR 1: INRATIO: 3.2, INRATIO: 3.3, INRATIO: 3.0, REFERENCE: 4.03, BIAS THRESHOLD: 3.03-5.03. DONOR 2: INRATIO: 1.6, INRATIO: 2.1, INRATIO: 1.8, REFERENCE: 1.90, BIAS THRESHOLD: 1.40-2.40. THE MINIMUM TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. PRECISION TESTING: DONOR 1: 1ST INR: 3.2, 2ND INR: 3.3, 3RD INR: 3.0, MEAN: 3.17, SD: 0.15, %CV: 4.82. DONOR 2: 1ST INR: 1.6, 2ND INR: 2.1, 3RD INR: 1.8, MEAN: 1.83, SD: 0.25, %CV: 13.73. SINCE % CV FOR BOTH DONORS ARE LESS THAN 16%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.0, LAB: 2.5. INRATIO: 2.0, LAB: 2.5. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE:(B)(6) 2011, INRATIO: 1.0. INRATIO: 2.0. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR. PATIENT'S COUMADIN DOSE WAS INCREASED FROM 6 MG TO 6.5 MG DUE TO METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 243932

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other