MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS SENOGRAPHE ESSENTIAL MAMMOGRAPHY UNIT; FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Poor Quality Image (1408)

Patient Problem Misdiagnosis (2159)

Event Date 10/11/2014

Event Type  Injury  

Event Description

In (b)(6) 2014, a patient came in to have a hookwire placed in her breast.Micro calcifications were seen on the craniocaudal (cc) regular magnification view but on no other views.The customer used the same parameters as usual and appropriate compression.There was no visible lump, discoloration, or other symptoms.Three months later, the patient went to another facility where a biopsy of the same area showed malignant micro calcifications.Subsequently, the patient had a 2.5cm cluster of malignant micro-calcifications removed that was originally diagnosed as benign instead of cancerous.According to the customer, they did misdiagnose the patient originally due to imaging incapability and poor visualization of micro-calcifications in magnification mammography views.

Manufacturer Narrative

The initial reporter is located outside the u.S., and therefore, this information is not provided due to country privacy laws.Additional manufacturer narrative: a follow-up mdr will be submitted should further information become available.

Manufacturer Narrative

The ge healthcare field engineer confirmed the system was functioning properly and passed all image quality tests.The product was determined to be within specifications and performing as designed for its intended use.Ge healthcare engineering analyzed the patient images and confirmed that the micro calcifications are visible on cranial-caudal (cc) projection, but not visible on standard medio-lateral-oblique (mlo) and the 3 magnification projections.Good clinical practices would have required to re-image the patient in magnification mode at the original projection cc where the calcification was initially located.Radiologist did actually perform magnification views, but in mlo, whereas the calcification was only visible in cc.The magnification views showed a lot of patient movements during acquisitions which caused to the degraded image quality.These images should have been retaken by the doctor per standard clinical practices.Radiologist stated she used the suboptimal images and misread them resulting in the diagnostic delay, hence "use" error.The misdiagnosis was due to user error.The radiologist performed an incomplete diagnostic in cc view (micro calcification seen but not diagnosed).In addition, the lack of re-imaging after patient motion led to blurry images.The user was trained by ge healthcare application specialist in (b)(6) 2009 for the system under investigation.In addition and as corrective action, the ge healthcare application specialist re-trained the customer (radiologist & technician) on (b)(6) 2015 about the proper patient positioning and the usage of the magnification mode.No further action is required as there is no malfunction of the system.

• Brand Name: SENOGRAPHE ESSENTIAL MAMMOGRAPHY UNIT
• Type of Device: FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc, 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc, 78530 ; FR 78530
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4878661
• MDR Text Key: 22067592
• Report Number: 9611343-2015-00004
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K131885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR