BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1971381 · Received January 11, 2011

    Report

    Report Number
    2027969-2011-00072
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: 1.4; REFERENCE: 8.0; MEAN: 4.70; CONFIDENCE LIMITS: 2.6-6.9. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY 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 COULD NOT BE PERFORMED BECAUSE STRIP LOT INFO WAS NOT PROVIDED BY THE CUSTOMER. NO FURTHER INVESTIGATION IS REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PT HAS LUNG CANCER AND ANEMIA. PT'S CURRENT HEALTH CONDITION MAY HAVE LED TO THE UNEXPECTED INR RESULTS. IN ADDITION, PT'S HEMATOCRIT WAS OUT OF RANGE. PER LIMITATIONS OF PRODUCT USE, PTS SHOULD BE WITHIN A 30-55% HEMATOCRIT RANGE, WHICH WILL NOT AFFECT INRATIO TEST RESULTS. COMPLAINT 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) 2010; INRATIO: 1.4; LAB: 8.0. PT WENT INTO A PANIC ATTACK AND WAS TAKEN TO THE HOSPITAL. HE OFTEN HAS PANIC ATTACKS DUE TO SEVERE LUNG CANCER, WHICH LEAVES HIM BARELY ABLE TO BREATHE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O