BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1984048 · Received January 13, 2011

    Report

    Report Number
    2027969-2011-00097
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 13, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    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: 1.2, REFERENCE: 2.6, MEAN: 1.90, CONFIDENCE LIMITS: 1.3-2.7. INRATIO: 1.2, REFERENCE: 2.7, MEAN: 1.95, CONFIDENCE LIMITS: 1.3-2.7. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT ACCURACY CRITERIA WAS MET. PER GENERAL DESCRIPTION OF COMPLAINT, CUSTOMER IS ON CHEMOTHERAPY AND TAKES LOVENOX. CUSTOMER DID NOT SPECIFY IF PATIENT WAS ON LOVENOX AT TIME OF COAGULATION TEST. PATIENT'S HEALTH CONDITION AND MEDICATION INTAKE MAY HAVE AFFECTED COAGULATION TEST AND MAY HAVE LED TO INACCURATE INR RESULTS. (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 RESULTS FROM A PREVIOUS CASE ON STRIP LOT #234130. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 234130 ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0). NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.2, LAB: 2.7. DATE: (B)(6) 2010, INRATIO: 1.2, LAB: 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 NI