BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1841367 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05623
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE EGD PROCEDURE, THE GOLD PROBE DEVICE WAS INSERTED INTO THE PATIENT AND POSITIONED WITHIN THE DUODENUM TO TREAT AN ULCER. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO ENGAGE THE PROBE, THE GOLD PROBE WOULD NOT EMIT ENERGY AND CAUTERIZE THE TISSUE. THE GOLD PROBE WAS USED IN CONJUNCTION WITH AN ENDOSTAT III GENERATOR AND AN ADAPTOR CORD. THE ACCOUNT REPORTED NO VISIBLE DAMAGE TO THE DEVICE. THE GOLD PROBE WAS NOT TESTED PRIOR TO INSERTING IT INTO THE PATIENT. A SECOND GOLD PROBE DEVICE, ALONG WITH THE SAME ADAPTOR CORD AND THE ENDOSTAT III GENERATOR, WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. 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 ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIT110

    Patients

    Seq Age Sex Outcome Treatment
    1