BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2277389 · Received September 29, 2011

    Report

    Report Number
    2027969-2011-02045
    Event Type
    Injury
    Date Received
    September 29, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER TECHNICAL SERVICES REPRESENTATIVE, PT WAS ON LOVENOX. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." QC ERRORS ARE DESIGNED TO BE GENERATED IF THE STRIP HAS BEEN EXPOSED TO ADVERSE ENVIRONMENTAL CONDITION. THERE IS NO INFORMATION IN THE COMPLAINT TO INDICATE STRIP EXPOSURE. THESE ERRORS ALSO ARISE IF THERE IS A SAMPLING OR TECHNIQUE PROBLEM. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF CORRECTIVE ACTION IS WARRANTED. (B)(4). NOTE BRICK LOT NUMBER 246550 HAS STRIP CODE TS4XB MATERIAL WAS SPLIT INTO THREE DIFFERENT LOTS, LOT # 253024 INTO 12 PACKS (SMALLER LOT), LOT # 243394 INTO 12 PACKS (SMALLER LOT), LOT # 253028 INTO 48 PACKS (LARGER LOT). THEREFORE, (B)(4) TOTAL COMPLAINTS HAVE BEEN REPORTED FOR LOT #'S 253024, 243394, 253028 YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF (B)(4), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF (B)(4), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CURSE CALLED IN BECAUSE PT HAD TWO QC2H ERROR MESSAGES WITH METER ON (B)(6) 2011. CUSTOMER WAS BEEN GETTING QC2H ERRORS FOR THE LAST SIX WEEKS WITH TWO DIFFERENT LOTS OF STRIPS. PT WAS HOSPITALIZED ON (B)(6) 2011 DUE TO A "MAJOR BLEED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 253024

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O