BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1840017 · Received September 21, 2010

    Report

    Report Number
    1823260-2010-05605
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 1, 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

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 598 MG/DL AND 151 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE 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 AN UNSPECIFIED TREATMENT PROCEDURE, A BALLOON DETACHMENT OCCURRED. A 20MM X 4.5MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE AND THE BALLOON DETACHED IN THE ARTERY. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BALLOON BY USING A TORQUEING TECHNIQUE AND WRAPPING WIRES AROUND THE BALLOON AND PULLING THE BALLOON OUT THROUGH THE GUIDE CATHETER. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS UNKNOWN.

    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 551339

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR GLIPIZIDE| NEXIUM| GABAPENTIN| VITAMIN D| TRILIPIX| SYNTHROID| WELCHOL| NITROSTAT| ATENOLOL| PROZAC