BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO

    MDR report key: 2185464 · Received July 22, 2011

    Report

    Report Number
    2027969-2011-01620
    Event Type
    Death
    Date Received
    July 22, 2011
    Date of Event
    April 4, 2011
    Report Date
    July 22, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS SHIPPED A STARTER KIT INCLUDING A METER, STRIPS AND 4 ALCOHOL PADS ON (B)(6) 2010. (B)(4) ONLY SENDS OUT ALCOHOL PADS INCLUDED IN STARTER KITS. CUSTOMERS WERE DIRECTED TO CONTACT THEIR PHYSICIANS FOR MEDICAL ADVICE AND WERE PROVIDED (B)(4) AND (B)(4). THE METER WAS RETURNED TO (B)(4) ON (B)(4) 2011. THIS PATIENT WAS TRAINED ON (B)(6) 2010. THE PATIENT REPORTED 3 RESULTS WHILE ON SERVICE 8/29 = 2.4 (RECEIVED FROM TRAINING DOCUMENTS), 12/14 = 2.7 AND (B)(6) 2010 = 1.8. UPON RETURN OF MONITOR ON (B)(6) 2011, THE FOLLOWING ADDITIONAL RESULTS WERE RETRIEVED. BUT THE PATIENT MUST HAVE ALTERED THE DATE/TIME AS THE RESULTS REPORTED ARE FROM A TIME BEFORE THE PATIENT WAS TRAINED. SIX RESULTS FROM (B)(6) 2009-(B)(6) 2011 THAT WERE RETRIEVED UPON RETURN. THE LAST RESULT ON (B)(6) 2011 WAS 1.1 (WITHIN THE NORM FOR A NON TREATED INDIVIDUAL). HIS RX LISTS MULTIPLE COMORBIDITIES. INFORMATION PROVIDED BY THE PATIENT CANNOT DEFINITIVELY RULE OUT THAT PATIENT'S INFECTION WAS CAUSED BY THE ALCOHOL PADS, BUT THE LIKELIHOOD OF THIS IS LOW BASED ON THE ORIGINAL SHIP DATE OF THE STARTER KIT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT'S WIFE (B)(6) CALLED (B)(4) REP (B)(4) TO TALK ABOUT THE NOTICE SHE RECEIVED REGARDING THE ALCOHOL PREP PADS. CALLER STATED THAT HER HUSBAND DIED IN APRIL FROM A BACTERIAL INFECTION AND THAT HE USED ALCOHOL PADS WHEN TESTING. WIFE STATED SHE HAD NO WAY OF KNOWING WHETHER OR NOT THESE 4 WERE THE PADS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death