BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ADVANTAGE II TEST STRIPS

    MDR report key: 2954298 · Received February 11, 2013

    Report

    Report Number
    1823260-2013-00810
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    March 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER TESTED 220 MG/DL ON THE ADVANTAGE II SYSTEM. AFTER OBTAINING THIS RESULT, SHE TOOK GLIMEPIRIDE; 20 MINUTES LATER THE CUSTOMER REPORTED HYPOGLYCEMIC SYMPTOMS AND SHE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER TESTED 40 MG/DL ON A PROFESSIONAL DEVICE AND WAS TREATED WITH GLUCOSE AND HER LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58845 ACCU-CHEK ® ADVANTAGE II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 571640

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR Hospitalization| R