MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. PATHWAY HER2 (4B5); SYSTEM, TEST, HER-2/NEU, IHC

Catalog Number	05278368001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Breast Cancer (1759)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A customer from the united states alleged an impact to patient treatment based on false negative results for a patient sample stained with pathway anti-her-2/neu (4b5) rabbit monoclonal antibody test.An investigation was performed to evaluate the customer issue.No product problem was identified.Review of the batch monitoring dashboard indicated that alleged lot was compliant with all quality criteria at the time of release.Furthermore, per the customer report, the alleged lot was used to completion and did not produced erroneous results any other time.Additional information such as patient's treatment outcome as well as current treatment based on updated her-2 results, or staining images of the initial and retest results, has been requested but not provided.The customer indicated that although the controls containing positive and negative breast tissue are cut ahead of time, every two weeks, and are stored on the counter presently, however they were previously stored in the refrigerator.Per the product method sheet - positively charged slides may be susceptible to environmental stresses resulting in inappropriate staining of any ihc assay (for example, lack of primary antibody or counterstain on the tissue.Based on the available information, storage of the initial control slides in the refrigerator, most likely adversely impacted slide fluidics and therefore is the most likely contributing factor of the alleged issue.(b)(4).
Event or Problem Description
A customer from the united states alleged an impact to patient treatment based on false negative results for a patient sample stained with pathway anti-her-2/neu (4b5) rabbit monoclonal antibody test.The customer reported that the patient underwent a needle & skin punch biopsy in (b)(6) 021 for collection of tissue sample for testing.On (b)(6) 2021, patient's primary breast tumor sample was tested, yielding negative her-2 result.The negative results were released to the patient's treating physician.The patient's initial diagnosis was reportedly invasive ductal carcinoma and the pathologist onsite stated that the patient had chemotherapy with pathologic complete response, clinically responded on radiology.On (b)(6) 2021, the patient had a double mastectomy, including lymph nodes, right axillary regional resections.No residual disease was detected after mastectomy in breast and axillary lymph nodes.However, a repeat pet scan indicated the presence of residual lesions in the axillary.Therefore, on (b)(6) 2021, patient's breast lymph node sample was tested, yielding a positive her-2 result.The initial primary tumor sample was then repeat tested, this time yielding a positive her-2 result.Please note, breast markers were not run on the lymph node sample during initial tests on (b)(6) 2021.Also, no er/pr tests done on the primary tumor sample during repeat tests in (b)(6) 2021, only her-2 test was repeated on this sample.The patient's final diagnosis was metastatic breast cancer.The customer additionally alleged that although the patient received chemotherapy, they did not receive herceptin as part of treatment due to the initial her-2 negative results.Please note that there is no information regarding the patient's treatment outcome from the treating physician.The customer communicated that on (b)(6) 2021 there was an amendment to update the her-2 test results (negative/0 to positive/3+), but with no change in diagnosis.An investigation was performed to evaluate the customer issue.

• Brand Name: PATHWAY HER2 (4B5)
• Common Device Name: SYSTEM, TEST, HER-2/NEU, IHC
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 12724503
• Report Number: 2028492-2021-00007
• Device Sequence Number: 15224534
• Product Code: MVC
• UDI-Device Identifier: 04015630972197
• UDI-Public: 04015630972197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 05278368001
• Device Lot Number: G23061
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 67