BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2072886 · Received April 29, 2011

    Report

    Report Number
    1823260-2011-02317
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED THE CUSTOMER TOOK PRESCRIBED 20 UNITS OF LANTUS AT 06:50 AM, HAD AN ADVANTAGE SYSTEM BLOOD GLUCOSE RESULT OF 202 MG/DL AT AROUND 07:00 AM. THE CUSTOMER PASSED OUT AT 07:10 AM, HUSBAND CALLED AMBULANCE. EMTS SYSTEM RESULT AT 07:15 AM WAS 36 MG/DL. EMTS TREATED HER WITH GLUCOSE, TRANSPORTED HER TO HOSPITAL WHERE SHE WAS TREATED WITH FOOD, ADMITTED FOR FIVE DAYS. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551434

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR LANTUS| NOVOLOG| SIMVASTATIN| VERAPAMIL 1XDAY| ASPIRIN| LISINOPRIL 1XDAY