BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST STRIPS

    MDR report key: 2220856 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04516
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 31, 2011
    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
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 5.0 MMOL/L AND 6.0 MMOL/L ON CUSTOMER'S COMPACT PLUS SYSTEM AT A TIME WHEN THE CUSTOMER PRESENTED SYMPTOMS OF HYPOGLYCEMIA, REQUIRED TREATMENT BY LAYPERSON. FIANCEE TREATED WITH SWEET THINGS TO EAT. IT TOOK ONE HOUR TO GET HIM OUT OF THIS STATE; HE WAS STILL RECOVERING AT THE TIME OF THE CALL. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208024

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR Required Intervention VICTOZA 1XDAY| LANTUS 2XDAY| NOVORAPID 1XDAY