MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Breast Cancer (1759); Misdiagnosis (2159)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

This mdr will be supplemented when additional information is received.This incident was communicated to siemens by (b)(6) m.D.Via email.Additional information is being collected and an investigation is in-progress.The system is not being returned, but a failure analysis can be conducted via alternate methods.Reference complaint # (b)(4).

Event Description

It was reported that a (b)(6) year old female patient presented with a vague palpable complaint the size of nickel in her lateral right breast.Her breast density was heterogeneously dense.The patient denied other symptoms and she was of average risk as having had several normal mammograms in the past.Her 2d/3d mammo was reported as normal and both the images taken by the tech and the subsequent spot check by the radiologist were normal.The patient was told to follow up with her physician for a short term clinical exam to recheck her complaint which was thought to be normal lumpy breast tissue by the radiologist.During peer review two weeks later i noticed an asymmetric regional focal asymmetry in the lateral breast much larger than the patient's described palpable complaint with somewhat indistinct trabecular markings without a discreet mass or distortion.The patient was invited back to the clinic to be re-imaged.Using the ge logic 9, dr.(b)(6) found a diffusely infiltrative process manifest as a regional relative decreased echogenicity in the lateral left breast corresponding to the developing regional focal asymmetry which was also much larger than the patient's description of her clinical complaint.The physical exam revealed a subtle but definite asymmetry to the texture of her lateral left breast in comparison to the lateral hemisphere of the right breast.The patient was coded as a bi-rads 4 and had an ultrasound biopsy the same day by sampling the lesion in both the epicenter of her complaint and the anterior margin of the abnormal echo texture.The pathology results were both invasive lobular carcinoma.The patient declined nac, and was staged as node negative at the time of her bilateral mastectomy.No additional information was provided.

Manufacturer Narrative

Evaluation results: based on the limited information obtained and an internal side by side comparison of the customer settings compared to the factory default settings, the results indicate there is no system malfunction.Because of the user dependency with ultrasound, the investigation can only evaluate the system performance.As indicated by the physician's email, there were other indications in the mammography and other imaging tests, that the breast ca was visible.This would infer that this misdiagnosis was not missed solely by ultrasound.

• Brand Name: ACUSON S2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: christine dunn ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4255571795
• MDR Report Key: 8166412
• MDR Text Key: 130465575
• Report Number: 3009498591-2018-00050
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACUSON S2000
• Device Catalogue Number: 10041461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR