BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1803105 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04884
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING DILATATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, AN ATTEMPT WAS MADE TO INFLATE THE VOYAGER BALLOON DILATATION CATHETER USING AN UNSPECIFIED INFLATION DEVICE; HOWEVER, DIFFICULTY WAS EXPERIENCED INFLATING THE BALLOON AND BLOOD CAME BACK INTO THE INFLATION DEVICE. THE DEVICE WAS REMOVED AND ANOTHER ATTEMPT WAS MADE TO DILATE THE VESSEL USING A SECOND VOYAGER BALLOON DILATATION CATHETER; HOWEVER, THE SAME OCCURRED. THE SITE REPORTED THAT BOTH BALLOONS WERE RUPTURED, BUT THE RUPTURES MAY HAVE BEEN CAUSED BY THE INFLATION DEVICE. REPORTEDLY, THE INFLATION GAUGE WAS NOT WORKING; THEREFORE, THE INFLATION PRESSURE COULD NOT BE DETERMINED. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 201 MG/DL, 71 MG/DL AND 162 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. 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 ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20720641

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR GLYBURIDE/METFORMIN