BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3241282 · Received July 22, 2013

    Report

    Report Number
    1823260-2013-04407
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    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 AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 194 MG/DL, 93 MG/DL, AND 44 MG/DL WITHIN 10 MINUTES. CALLER REPORTED SYMPTOMS OF HYPOGLYCEMIA WITH THE 194 RESULT. CUSTOMER WAS ABLE TO SELF-TREAT. AFTER THE READING OF 93, CUSTOMER ATE PART OF AN APPLE. AFTER THE 44 READING, CUSTOMER FINISHED EATING THE APPLE. NO ADVERSE EVENT WAS REPORTED. 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
    340395 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551922

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR NOVOLOG 3XDAY| METFORMIN 2 X A DAY| LANTUS 2XDAY