MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD. HERCEPTEST FOR AUTOMATED LINK PLATFORMS; SYSTEM, TEST, HER-2/NEU, IHC

Model Number	SK001
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu will be further reviewed and the correct fixation time will be implemented in the next revision.
Event or Problem Description
Company representative reported unnecessary gastric biopsy procedure.Patient sample was tested for her2 utilizing the product herceptest (sk001).The product instructions for use (ifu) states the samples should be "fixed for 18-24 hours in neutral-buffered formalin" and also mentions that "biopsy samples in a toga trial were fixed for 6-8 hours".The user misinterpreted the ifu by applying the toga trial criteria for biopsy specimen fixation.As a result, patient being tested for eligibility in a clinical trial had the original specimen disqualified which resulted in an unnecessary biopsy procedure.Patient experienced no adverse effects from the re-biopsy procedure.
Event or Problem Description
Company representative reported unnecessary gastric biopsy procedure.The sk001 herceptest product instructions for use (ifu) states the samples should be "fixed for 18-24 hours in neutral-buffered formalin" and also states that "biopsy samples in a toga trial were fixed for 6-8 hours".With two fixation times listed in the ifu, sample fixation conditions are unclear and in this case were misinterpreted by narrowly applying the toga trial criteria for biopsy specimen fixation.Unclear ifu language resulted in patient receiving another biopsy procedure.Patient experienced no adverse effects from the re-biopsy procedure.

• Brand Name: HERCEPTEST FOR AUTOMATED LINK PLATFORMS
• Common Device Name: SYSTEM, TEST, HER-2/NEU, IHC
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD.; no. 1 yishun avenue 7; 76892 3; SN 768923
• MDR Report Key: 12442934
• Report Number: 3003423869-2021-00267
• Device Sequence Number: 17056777
• Product Code: MVC
• UDI-Device Identifier: 05700572032007
• UDI-Public: 05700572032007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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 Model Number: SK001
• Device Catalogue Number: SK00121-5
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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: Hospitalization; Other
• Patient Age: 72 YR