MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO OMNIS; AUTOMATED SLIDE STAINER

Model Number	GI100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the netherlands reported that on (b)(6) 2024 the customer ran a test for estrogen receptor (er) and progesterone receptor (pr) and the 2 results were "completely negative, both the controls and the patient material" with only "some hematoxylin staining was visible".The positive controls were on the same slide with the patient sample.Although the positive controls were negative, the patient sample was released as a negative result.The positive controls were confirmed as staining positive for er and pr before and after (b)(6) 2024 and were used within the expiration timeframe.As of (b)(6) 2025, a later sample of the same patient was tested, and the results were positive.The customer then re-stained the original november sample, and the results were now positive, making the november test results, false negative.It was confirmed the november results were released to the patient, and this is currently under investigation at the hospital.On the same rack/run as the november staining, 3 other markers were successfully stained.Several successful stainings of the same antibody vials were run before and after (b)(6) 2024 in the same machine and in 2 other instruments without issue.The customer could not find any error logs for (b)(6) 2024 and has not yet provided the protocol used or relevant images.The agilent field service engineer (fse) serviced the instrument and found no issues with the instrument.The instrument is fully operational and ready for use.Information regarding patient impact has not been provided.The customer confirmed they have reported this issue to the health and youth inspectorate (meldpunt).The customer's meldpunt report number was not provided.Agilent has not received a copy of the report for the customer's internal investigation, the health status of the patient, or a copy of the report provided to meldpunt.The investigation is ongoing.A follow up report will be provided when new information is received.".
Additional Manufacturer Narrative
This supplemental is being submitted to document the final outcome of the investigation and additional information received.The following fields were updated: b4, b5, g1, g3, g6, h2, h6, h7, h11.
Event or Problem Description
A customer in the netherlands reported that on (b)(6) 2024 the customer ran a test for estrogen receptor (er) and progesterone receptor (pr) and the 2 results were "completely negative, both the controls and the patient material" with only "some hematoxylin staining was visible".The positive controls were on the same slide with the patient sample.Although the positive controls were negative, the patient sample was released as a negative result.The customer admitted they did not realize the positive controls were negative for this run.The positive controls were confirmed as staining positive for er and pr before and after (b)(6) 2024 and were used within the expiration timeframe.As of (b)(6) 2025, a later sample of the same patient was tested, and the results were positive.The customer then re-stained the original (b)(6) sample, and the results were now positive, making the (b)(6) test results, false negative.It was confirmed the (b)(6) results were released to the patient, and this is currently under investigation at the hospital.On the same rack/run as the (b)(6) staining, 3 other markers were successfully stained.Several successful stainings of the same antibody vials were run before and after (b)(6) 2024 in the same machine and in 2 other instruments without issue.The customer could not find any error logs for (b)(6) 2024 and has not provided the protocol used or relevant images.The agilent field service engineer (fse) serviced the instrument and found no issues with the instrument.The instrument is fully operational and ready for use.Information regarding patient impact has not been provided.The customer confirmed they have reported this issue to the health and youth inspectorate (meldpunt).The customer's meldpunt report number was not provided.Agilent has not received a copy of the report for the customer's internal investigation, the health status of the patient, or a copy of the report provided to meldpunt.As part of the investigation process, three documented good faith efforts (two email communications and one telephone outreach) were made to obtain additional information from the customer regarding the reported event.As of the date of this report, no response has been received from the customer.Based on the information available, including the customer's prior admission that the positive controls were not acknowledged as negative for the affected staining run, the investigation has determined that the most probable root cause of the false negative result being released to a patient is user error.Specifically, the operator did not follow the instructions for use (ifu), which require invalidation of a staining run in the event of control failure.As no further information can be obtained, the investigation is being closed.
Event or Problem Description
A customer in the netherlands reported that on (b)(6) 2024 the customer ran a test for estrogen receptor (er) and progesterone receptor (pr) and the 2 results were "completely negative, both the controls and the patient material" with only "some hematoxylin staining was visible".The positive controls were on the same slide with the patient sample.Although the positive controls were negative, the patient sample was released as a negative result.The customer admitted they did not examine, nor realize, the positive controls were negative for this run.The positive controls were confirmed as staining positive for er and pr before and after (b)(6) 2024 and were used within the expiration timeframe.On (b)(6) 2025, it was confirmed by the customer the patient underwent an operation, "which could have possibly been prevented if the diagnosis was correct," and had resected tissue tested, and the results were positive.The customer then re-stained the original november sample, and the results were now positive, making the initial november test results, false negative.It was confirmed the november results were released to the patient.On the same rack/run for the november staining, 3 other markers were successfully stained.Several successful stainings of the same antibody vials were run before and after (b)(6) 2024 in the same machine and in 2 other instruments without issue.The customer could not find any error logs for (b)(6) 2024.The agilent field service engineer (fse) serviced the instrument and found no issues with the instrument.The instrument is fully operational and ready for use.The fse reviewed the logs and found no errors from a technical standpoint.The customer confirmed they have reported this issue to the health and youth inspectorate (meldpunt).The customer's meldpunt report number was not provided.After multiple attempts for additional details, the customer has confirmed they will not provide information regarding patient impact, patient health status, details regarding the operation, the meldpunt report, or the hospital's internal investigation.Based on the information available, including the customer's prior admission that the positive controls were not acknowledged, nor examined, as negative for the affected staining run, the investigation has determined that the most probable root cause of the false negative result being released to a patient is abnormal use.Specifically, the operator did not follow the instructions for use (ifu), which require invalidation of a staining run in the event of control failure.As no further information can be obtained, the investigation is being closed.
Additional Manufacturer Narrative
This supplemental is being submitted as additional information has been received.The following fields were updated: b4, b5, g3, g6, h2, h11.

• Brand Name: DAKO OMNIS
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612 ; 5123328207
• MDR Report Key: 21859568
• Report Number: 3003423869-2025-00022
• Device Sequence Number: 20812485
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: (01)05700573004904(11)171214
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/16/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown