BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2220857 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04517
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    REPORTER ALLEGED OBTAINING THE RESULTS OF 384 MG/DL, 95 MG/DL AND 509 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER STATED THAT SHE HAD TAKEN "22 MG OF LANTUS BY PEN" AN HOUR PRIOR TO TESTING. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 551448

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR LANTUS INSULIN| JANUVIA| METFORMIN| HYDROCHLOROTHIAZIDE| CINNAMON| VITAMIN C| FLAX SEED| CLARITIN| VITAMIN D| GLUCOSAMINE| INSULIN PEN| CENTRUM| LISINOPRIL