BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENOGRAPHE ESSENTIAL MAMMOGRAPHY UNIT

    MDR report key: 5706260 · Received June 8, 2016

    Report

    Report Number
    9611343-2016-00008
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    June 13, 2013
    Report Date
    July 26, 2016
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MUE
    PMA / PMN Number
    K131885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT AGE AND WEIGHT COULD NOT BE OBTAINED TO DATE. REPORT SOURCE OTHER: USER REPORT MW5061306. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE (GEHC) RECEIVED A USER MEDWATCH REPORT ON MAY 10 2016 WHERE A PATIENT REPORTED THAT IN (B)(6) 2013, SHE HAD A MAMMOGRAM DONE BECAUSE SHE FELT A LUMP IN HER LEFT BREAST DURING MONTHLY SELF-CHECK - DIAGNOSIS WAS NO CANCER FOUND. THE SITE LOST ITS ACR ACCREDITATION DUE TO SUBOPTIMAL IMAGES AND IN 2015, PATIENT RECEIVED A LETTER FROM THE FACILITY STATING FDA HAD CONCERNS WITH RESULTS OF MAMMOGRAMS DONE DURING CERTAIN TIME PERIOD DUE TO SUBOPTIMAL IMAGING AND HER MAMMOGRAM FELL INTO THAT CATEGORY. THERE WAS NO ALLEGATION OF GE HEALTHCARE MAMMOGRAPHY UNIT MALFUNCTION. IN 2015 SHE HAD REPEAT MAMMOGRAM DONE AT DIFFERENT FACILITY AND RESULTS STATED TO SEE A DOCTOR AND GET ULTRASOUND. IN 2016, SHE GOT ULTRASOUND AND UPON DOCTOR REVIEWING ULTRASOUND SHE RECEIVED A BIOPSY THE NEXT WEEK. TWO WEEK POST BIOPSY WAS TOLD THAT SHE HAS DUCTUAL CARCINOMA IN SITU IN LEFT BREAST AND DATE 2 INVASIVE DUCTUAL CARCINOMA IN RIGHT BREAST. SHE MET WITH SURGEON WHO RECOMMENDED A DOUBLE MASTECTOMY WITH CHEMOTHERAPY FOR 8 MONTHS. BASED ON THIS REPORTED INFORMATION, IT HAS BEEN DETERMINED ON (B)(6) 2016 THAT THE MAMMOGRAPHY SYSTEM MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WHICH WAS INITIALLY ASSESSED AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    GE HEALTHCARE RECEIVED AN FDA MEDWATCH REPORT ON MAY 10, 2016, WHERE A PATIENT REPORTED THAT IN (B)(6) 2013, SHE HAD A MAMMOGRAM BECAUSE SHE FELT A LUMP IN HER LEFT BREAST DURING MONTHLY SELF-CHECK. DIAGNOSIS WAS NO CANCER FOUND. IN 2015, SHE RECEIVED A LETTER FROM THE (B)(6) CENTER STATING FDA HAD CONCERNS WITH RESULTS OF MAMMOGRAMS DONE DURING CERTAIN TIME PERIOD AND HER MAMMOGRAM FELL INTO THAT CATEGORY. IN 2015 SHE HAD A REPEAT MAMMOGRAM DONE AT A DIFFERENT FACILITY AND RESULTS STATED TO SEE A DOCTOR AND GET AN ULTRASOUND. IN 2016, SHE GOT AN ULTRASOUND AND UPON DOCTOR REVIEWING THE ULTRASOUND, SHE RECEIVED A BIOPSY THE NEXT WEEK. TWO WEEKS POST BIOPSY, SHE WAS TOLD THAT SHE HAS DUCTAL CARCINOMA IN SITU IN LEFT BREAST AND DATE 2 INVASIVE DUCTAL CARCINOMA IN RIGHT BREAST. SHE MET WITH SURGEON WHO RECOMMENDED A DOUBLE MASTECTOMY WITH CHEMOTHERAPY FOR 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361966 SENOGRAPHE ESSENTIAL MAMMOGRAPHY UNIT FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMM MUE GE MEDICAL SYSTEMS SCS XGS042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention