BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1863890 · Received October 11, 2010

    Report

    Report Number
    1823260-2010-06038
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 432 MG/DL AND 150 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER DRANK WATER AFTER OBTAINING THE REPORTED RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE WITHDRAWAL RESISTANCE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED, 2.75X25MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A KINETIX GUIDEWIRE WAS ADVANCED TO THE LESION AND PASSED THE LATERAL BRANCH. A NON BSC GUIDEWIRE WAS THEN ADVANCED TO THE TARGET LESION AND THE PHYSICIAN ATTEMPTED TO REMOVE THE KINETIX GUIDEWIRE FROM THE PATIENT. HOWEVER, DURING ATTEMPTS TO REMOVE THE WIRE THE DEVICE BECAME CAUGHT ON THE NON BSC GUIDE CATHETER. THE GUIDEWIRE AND THE GUIDE CATHETER WERE REMOVED TOGETHER AS A SYSTEM AND IT WAS NOTED THAT THE DEVICES WERE UNABLE TO BE SEPARATED ONCE THEY WERE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PREDILATING THE LESION AND PLACING A NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION IS GOOD.

    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 551175

    Patients

    Seq Age Sex Outcome Treatment
    1