BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1924229 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07415
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REPORTED THE ADVANTAGE METER GAVE A RESULT OF 90 MG/DL AT A TIME WHEN HER HUSBAND WAS SYMPTOMATIC OF HYPOGLYCEMIA. WIFE THEN CALLED THE PARAMEDICS, THEIR SYSTEM RESULT 10-15 MINUTES LATER WAS 27 MG/DL. CUSTOMER WAS TREATED, ADMITTED TO HOSPITAL FOR 3 DAYS. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED A PERFORMANCE DECREMENT, AND PAIN WITH, AND WITHOUT, USE OF THE DEVICE. THE PATIENT HAS STOPPED USING THE DEVICE. REVISION SURGERY IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2010.

    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 551228

    Patients

    Seq Age Sex Outcome Treatment
    1 093 YR Hospitalization HUMULIN 70/30 2XDAY