BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO TEST KITS 12

    MDR report key: 9092951 · Received September 19, 2019

    Report

    Report Number
    2027969-2019-00434
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    January 8, 2013
    Report Date
    September 23, 2019
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    Removal / Correction Number
    Z-2354,2362-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D2 INFORMATION FROM GIS TO GJS.

    Additional Manufacturer Narrative · 1

    THIS MDR IS A RETROSPECTIVE FILING THAT WAS IDENTIFIED DURING AN INTERNAL ASSESSMENT AS PART OF CAPA (B)(4) RELATED TO UNMONITORED COMMUNICATIONS CHANNELS (E-MAILS, VOICEMAILS). INVESTIGATION RESULTS: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. A LOT NUMBER OF THE TEST STRIP PRODUCT WAS NOT PROVIDED AND NEITHER MANUFACTURING RECORD REVIEW NOR TESTING ON RESERVE SAMPLE FROM THE SAME LOT COULD NOT BE PERFORMED. FURTHER INVESTIGATION IS NOT POSSIBLE AT THIS TIME. ALERE HAS WITHDRAWN THE ALERE INRATIO®/INRATIO®2 PT/INR SYSTEM FROM THE MARKET AND IS NO LONGER MANUFACTURING INRATIO® TEST STRIPS AND MONITORS. IN ADDITION, ALL ALERE INRATIO® TEST STRIPS ARE NOW EXPIRED. CUSTOMERS HAVE BEEN ADVISED TO WORK WITH THEIR HEALTHCARE PROVIDER TO TRANSITION TO AN ALTERNATE MONITORING METHOD, SUCH AS A PLASMA-BASED LABORATORY INR METHOD OR A POINT-OF-CARE MONITORING SYSTEM FROM A DIFFERENT MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DUE TO THE DISCREPANT LOW 1X ON THE INRATIO MONITOR THE PHYSICIAN DOES NOT WANT TO USE THE MONITOR BUT THE LAB ONLY. RESULTS WERE 1/8/13: INRATIO RESULT WAS 3.1, LAB BLOOD DRAW RESULT WAS 3.9. THE SAME VARIANCE WAS APPARENT ON THE PREVIOUS TEST. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880275 INRATIO TEST KITS 12 INRATIO PRO TIME TEST GJS ALERE SAN DIEGO 100071

    Patients

    Seq Age Sex Outcome Treatment
    1