BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1813297 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05044
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 255 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 80 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.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PT WAS NOT SUITABLE FOR AAA REPAIR DUE TO NARROW TERMINAL AORTA (14 X 23 MM). FINAL ANGIO REVEALED TYPE II, TYPE III, AND POSSIBLE TYPE IV ENDOLEAKS. ANOTHER MFR'S STENT WAS PLACED RIGHT OF THE JUNCTION PART AND TYPE III ENDOLEAK WAS RESOLVED. PHYSICIAN DECIDED ON FOLLOW UP OBSERVATION SINCE TYPE II ENDOLEAK AND TYPE IV ENDOLEAK (1820334-2010-00442) WERE THOUGHT TO BE DUE TO ACT OVER 300. ON (B)(6) 2010, ANGIOGRAPHY CT REVEALED TYPE III ENDOLEAK FROM LEFT SIDE OF THE JUNCTION PART AND TYPE II ENDOLEAK. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER MFR'S STENT MOUNTED ON BALLOON AT THE JUNCTION, HOWEVER THE STENT DROPPED FROM THE BALLOON. SEVERAL ATTEMPTS TO RETRIEVE THE STENT WERE UNSUCCESSFUL. THE PHYSICIAN PLACED IT NEAR THE DISTAL SIDE OF THE LEFT ILIAC LEG. A DIFFERENT MFR'S STENT WAS PLACED AT THE LEFT SIDE OF THE JUNCTION PART INSTEAD, BUT ENDOLEAK WAS NOT RESOLVED. ANOTHER OF THAT SAME MFR'S STENT WAS PLACED AT THE PART BUT WAS ALSO INVALID. THE PHYSICIAN DECIDED TO FOLLOW UP (1820334-2010-00444). IT WAS NOTED THAT PULSE OF RIGHT FEMORAL ARTERY WAS WEAK, AND ANGIOGRAPHY WAS PERFORMED AGAIN. IT REVEALED LEFT EXTERNAL ILIAC ARTERY GOT INTIMAL DISSECTION AND THOUGHT TO BE CAUSED WHEN THE OTHER MFR'S STENT WAS ATTEMPTED TO BE RETRIEVED. THEN FEM-TO-FEM BYPASS SURGERY WAS PERFORMED. THE PT'S CONDITION WAS NOT PROVIDED BY THE REPORTER.

    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 551175

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG (THRICE DAILY)| LANTUS (NIGHTLY)