BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® LANCET DEVICE

    MDR report key: 1874577 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06216
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    REPORTER ALLEGED THE NEEDLE FROM THE SOFTCLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PACING IMPEDANCE WAS GRADUALLY INCREASING SINCE IMPLANT TO OVER 1500 OHMS, BUT PHYSICIAN SAID IT WAS RELATED TO THE "TISSUE INTERFACE, NOT AN INTEGRITY ISSUE". VENTRICULAR TACHYCARDIA AND NON-SUSTAINED TACHYCARDIA EPISODES WERE NOTED. THE PATIENT WAS BROUGHT TO THE ER PER PHYSICIAN'S INSTRUCTION AFTER THE DEVICE HAD "GONE OFF SEVERAL TIMES". IT WAS DETERMINED THAT THE PATIENT HAD NOT BEEN SHOCKED, BUT RATHER MEANT THE PATIENT ALERT HAD BEEN RINGING. REPROGRAMMING WAS DONE AND PATIENT WAS DISCHARGED WITH INSTRUCTIONS TO BEEN SEEN BY THE CLINIC IN TWO WEEKS. NINE DAYS AFTER ER VISIT, THE PATIENT DIED ON (B)(6) 2010 WITH CAUSE OF DEATH NOTED TO BE ACUTE HEART FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIN232

    Patients

    Seq Age Sex Outcome Treatment
    1