BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1832523 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05399
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 28, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    A PATIENT FELT A SURGE IN STIMULATION JUST PRIOR TO HER DEVICE TURNING OFF UNEXPECTEDLY. THE PATIENT USED THEIR PROGRAMMER TO TURN THEIR DEVICE BACK ON. STIMULATION WORKED ONCE THE DEVICE WAS TURNED BACK ON. THE PATIENT INDICATED SHE WAS EXPOSED TO A THEFT DETECTOR OR SECURITY GATE AT AN AIRPORT, WHILE THE DEVICE WAS TURNED ON. THE SOURCE OF DIRECT EXPOSURE WAS FROM A FULL BODY SCANNER. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 409 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 179 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALLEGED THAT ON A DIFFERENT DAY, SHE OBTAINED A RESULT OF 346 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 164 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO 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 551255

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR ZETIA (DAILY)| TYLENOL (DAILY)| LIPITOR (DAILY)| LISINOPRIL (TWICE DAILY)| METOPROLOL (TWICE DAILY)| "SIMPLY ONE WOMEN" (DAILY)| METFORMIN (DAILY)| FISH OIL (DAILY)