BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1802384 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04868
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    CATHETER FRACTURED DURING RE-WIRING PORTION OF MODIFIED SELDINGER TECHNIQUE FOR INSERTION OF A FEMORAL CENTRAL VENOUS CATHETER. UNABLE TO RETRIEVE INTERNAL PORTION. SURGICAL FEMORAL VEIN CUTDOWN DID NOT REVEAL CATHETER OUTSIDE OF THE VEIN. GUIDEWIRE WAS LEFT IN POSITION.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN ADVANTAGE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 215 MG/DL (ADVANTAGE) AND 109 MG/DL (DOCTOR'S METER) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 551288

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR ZETIA 1X DAILY| DIOVAN 1X DAILY| BLOOD PRESSURE CUFF| TOPROL 1X DAILY