BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2173346 · Received July 23, 2011

    Report

    Report Number
    1823260-2011-03916
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    August 4, 2011
    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
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED THE ADVANTAGE SYSTEM GAVE A BLOOD GLUCOSE RESULT 127 MG/DL AT A TIME WHEN THE PATIENT HAD SYMPTOMS OF HYPOGLYCEMIA. CUSTOMER CHOSE TO NOT SELF-TREAT BECAUSE THE RESULT WAS NOT LOW. HE CALLED HIS DAUGHTER, WHO DROVE HIM TO THE HOSPITAL, WHERE, A HALF HOUR LATER HIS BLOOD GLUCOSE WAS 55 MG/DL ON THE HOSPITAL SYSTEM. HOSPITAL TREATED WITH ORANGE JUICE AND AN UNSPECIFIED IV. 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 551479

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR Required Intervention STENT IN LEG| LANTUS| PACEMAKER