MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD BOND-PRIME AUTOMATED SLIDE STAINER; SLIDE STAINER, AUTOMATED

Model Number	BOND-PRIME AUTOMATED SLIDE STAINER
Medical Device Problem Codes	Off-Label Use (1494); Calibration Problem (2890)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the ¿false positive on her 2¿ reported by the customer was determined by the leica senior applications specialist to be a combination of off-label use of the her2 antibody and the use of an out of calibration asi imager.Based on the information available, the bond-prime functioned as designed in the circumstances reported by the complainant and was not a cause of the issue seen.
Event or Problem Description
On (b)(6) 2025, the customer contacted leica biosystems and reported ¿false positive on her 2 correlating with asi imager¿.The information available does not identify the specific staining run(s) where ¿false positive on her 2¿ was reported by the customer.Per the customer the information details of this event resulted in a 23-24% increase in positive cases from ¿last year¿.The customer documented they were contacted by the clinician with concerns as compared to last year ¿¿their her2 positive percentages were high.Comparing what their asi imaging scanner scored them as vs what their sent out test results were from [laboratory].[laboratory] stating that they were equivocal, fish negative.Customer said that their her2 breast cases that were scored 2+ really stated as low 3+ on their imaging system.Patients underwent treatment as such.¿ twenty (20) patient cases have been affected, with ¿patient¿s given treatment, treatment more toxic on patient¿s already undergoing treatments.¿ information provided by the leica senior applications specialist detailed the ¿customer was made aware that this was a class i qualitative antibody used on their bond prime instrument.I made sure to let them know before customer purchase that this antibody is not fda approved¿ and the customer ¿¿utilizes their asi imaging microscope for their breast scoring¿.I was not able to assist with anything regarding their scoring system due to not being a leica validated process with her2 antibody.¿ the leica senior applications specialist also detailed ¿pathologist was relying on scoring system for breast scores.Said he was not pulling cases and scoring under scope, was solely relying on imager system.¿ the bond-prime is not a recommended instrument as per the bond¿ ready-to-use primary antibody c-erbb-2 oncoprotein catalog no: pa0983 (7ml) instructions for use (ifu).The ifu recommends this antibody for use with the leica bond-max system and leica bond-iii system.This was communicated to the customer and the actions taken by the customer were by the customer's own disregard to leica's guidance.The customer ¿¿realized that their imager [a non-leica device] was out of calibration in relation to their light source.As well as a light flicker issue¿anytime light flicker issue occurs recalibration is required.¿ the pathologist requested leica biosystems to assist with ¿¿removing blushing in her2 leica antibody background.This can be a factor in the scoring of the asi imager.They are having [laboratory] repeat cases¿.Using [instruments] and [name] her2 fda approved antibody¿¿.

• Brand Name: BOND-PRIME AUTOMATED SLIDE STAINER
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley; victoria 00000-0314 ; AS 0000003149 ; 92117271
• MDR Report Key: 23659211
• Report Number: 8020030-2025-00071
• Device Sequence Number: 13275714
• Product Code: KPA
• UDI-Device Identifier: 09349458004828
• UDI-Public: (01)09349458004828(11)220622
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: BOND-PRIME AUTOMATED SLIDE STAINER
• Device Catalogue Number: 91.0021
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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
• Patient Sex: Unknown