BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2030202 · Received March 21, 2011

    Report

    Report Number
    2027969-2011-00553
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: >7.5; REFERENCE: 6.0; MEAN: NA; CONFIDENCE LIMITS: NA. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. BOTH INRATIO AND REFERENCE VALUES ARE GREATER THAN 5.0 INR. GENERALLY, INR RESULTS EXCEEDING 5.0 HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POINT-OF-CARE AND LABORATORY BASED PT TESTING. CONFIDENCE LIMITS COULD NOT BE ESTABLISHED. NO PRODUCT IS EXPECTED TO BE RETURNED. RECENT INVESTIGATION FROM A PREVIOUS CASE PERFORMED ON (B)(4) 2011 REVEALED THAT RESULTS FOR STRIP LOT #240450 MET ACCURACY CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 1: 1ST INR: 2.5; 2ND INR: 2.6; 3RD INR: 2.5; REFERENCE: 2.48. DONOR 2: 1ST INR: 3.0; 2ND INR: 3.2; 3RD INR: 3.3; REFERENCE: 3.12. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) FOR ACCURACY CRITERIA. NO FURTHER INVESTIGATION REQUIRED. (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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: >7.5; LAB: 6.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 240450

    Patients

    Seq Age Sex Outcome Treatment
    1 NI