BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ADVANTAGE

    MDR report key: 1941326 · Received December 29, 2010

    Report

    Report Number
    1823260-2010-07729
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 7, 2010
    Report Date
    March 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT. CALLER ATTEMPTED TO TEST THE CUSTOMER'S BLOOD SUGAR WITH THE ADVANTAGE METER, BUT THE METER HAD NO POWER. CUSTOMER WAS TAKEN TO THE HOSPITAL BY A FAMILY MEMBER, AND READING OF 25 MG/DL WAS OBTAINED ON THE CUSTOMER ON THE HOSPITAL'S METER. CUSTOMER WAS ADMITTED TO THE HOSPITAL AND TREATED WITH IVS (CONTENTS UNKNOWN). CUSTOMER WAS RELEASED THE NEXT DAY WITH A BLOOD SUGAR READING OF 65 MG/DL. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR Hospitalization ACTOS| GLYBURIDE