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

Model Number BOND-III

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

Patient Problem Insufficient Information (4580)

Event Date 10/10/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation of the information available, which includes the relevant run events and service events, indicates that the two (2) slides for which false positive staining was reported (hereafter referred to as the "affected slides") were: slide id (b)(6) with case id (b)(4), which was stained at slide position 5 on slide staining assembly (ssa) 1 in run 20651 executed on (b)(6) 2021, and slide id (b)(6) with case id (b)(4), which was stained at slide (b)(6) on ssa 1 in run 21164 executed on (b)(6) 2021.Staining of both affected slides was performed using bond-iii automated stainer serial number (b)(4); and both run 20651 and 21164 completed successfully with no recorded event(s) to suggest any malfunction(s) of the instrument.Additionally, slide id (b)(6) was stained in run 20651 together with two (2) other slides with bond slide ids (b)(6) and (b)(6)using the same staining protocol and the same reagents with no problem regarding the quality of staining reported to the manufacturer for slides with slide ids (b)(6); and slide id (b)(6) was stained in run 21164 together with three (3) other slides with bond slide ids (b)(6), using the same staining protocol and the same reagents, with no problem regarding the quality of staining reported to the manufacturer for slides with slide ids (b)(6).The information available also indicates that staining of both of the affected slides was performed using on-the-instrument factory default *dewax protocol, with factory default heat induced epitope retrieval (hier) protocol *hier 40 min and er1/ and custom staining protocol "her2 joes dab" with leica biosystems bond ready-to use primary antibody *c-erbb-2 oncoprotein (clone cb11) catalog no: pa0571 and the bond polymer refine detection kit.The bond ready-to-use primary antibody c-erbb-2 oncoprotein (cb11) instructions for use contain the following information: "the clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist," and "c-erbb-2 oncoprotein (cb11) primary antibody was developed for use on the automated bond system (includes leica bond-max system and leica bond-iii system) in combination with bond polymer refine detection.The recommended staining protocol for c-erbb-2 oncoprotein (cb11) primary antibody is ihc protocol f.Heat induced epitope retrieval is recommended using bond epitope retrieval solution 2 for 20 minutes." the facts indicate that the bond ready-to-use primary antibody c-erbb-2 oncoprotein (cb11) was not used in accordance with the manufacturer recommendations detailed in the instructions for use (ifu), because the available information indicates that the affected slides were stained using bond epitope retrieval solution 1 for 40 minutes rather than the recommended bond epitope retrieval solution 2 for 20 minutes; and the custom "her2 joes dab" protocol used for staining of the affected slides is not identical to the recommended ihc protocol f.Leica biosystems melbourne cannot assess the impact this may or may not have had on the quality of staining of the affected slides.The information available indicates that" the controls stained appropriately" in runs 20651 and 21164.However, the information available does not indicate either the type of control tissue used or whether the control tissue was placed on the same slide as the patient tissue, in accordance with the instrument manufacturer recommendations in section 6.2 of the leica biosystems bond system user manual for bond systems running bond 6.0 software (for use only in the usa) entitled "working with controls", which details the following: "to most adequately test the performance of the bond system, leica biosystems strongly recommends placing appropriate control tissue on the same slide as patient tissue." the information available suggests that run 20651 and run 21164 had both positive and negative tissue control, which stained as expected.However, information available does not indicate the type of control tissue used and whether they were placed on the same slides as the tissue for case id (b)(4) and case id (b)(4), in line with the instrument manufacturer recommendations in section 6.2 of the leica biosystems bond system user manual for bond systems running bond 6.0 software (for use only in the usa) entitled "working with controls." the run events for run 20651 and run 21164 do not suggest that slides with control tissue were placed on the same ssa as bond slide id (b)(6) with case id (b)(4) and bond slide id (b)(6) for case id (b)(4).Manufacturer evaluation of the information available did not identify any instrument-related root cause for the reported (b)(6) staining of bond slide id (b)(6) with case id (b)(4) and bond slide id (b)(6) for case id (b)(4), following processing using bond-iii automated stainer serial number (b)(4).The root cause of the false positive staining reported by the complainant on 30 december 2021 could not be determined from the information available.

Event Description

The leica (b)(4) applications specialist north america (fas) received an email from the laboratory supervisor on (b)(6) 2021 detailing that the laboratory was experiencing staining issues the c-erb-2 clone cb11 antibody product number pa0571 and were concerned that there may be two misdiagnosed patients due to overstaining with this antibody, which had resulted in false positive results.On (b)(6) 2021, leica biosystems (b)(4) received the following further details from the fas, which had been provided by the laboratory supervisor: "that they had a patient that was misdiagnosed on (b)(6) 2021 according to a positive her-2 result.The patient received chemotherapy based on the positive result.On (b)(6) 2021 there was a 2nd patient with questionable results.The clinician asked for a repeat of the 2nd patient specimen which turned out to be negative.The negative result from the 2nd patient prompted the lab to re-test the 1st patient from (b)(6).The repeat specimen from (b)(6) was negative.The clinician was notified of the corrected result.The clinician informed the lab the patient had already started chemotherapy." on (b)(6) 2022, leica biosystems (b)(4) received information that the identifier for the patient case stained on (b)(6) 2021 was (b)(4) and repeat staining was performed by fish on a different instrument platform (unspecified); and the identifier for the patient case stained on (b)(6) 2021 was (b)(4) and repeat staining was performed on (b)(6) 2021 using bond-iii automated stainer serial number (b)(4).On (b)(6) 2021, leica biosystems (b)(4) received an identifier, age and gender for each of the two (2) affected patients.Refer to report mrf # 8020030-2022-00009 for specific details of the other patient involved.

• Brand Name: BOND-III AUTOMATED STAINER
• Type of Device: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 13382283
• MDR Text Key: 289609637
• Report Number: 8020030-2022-00010
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BOND-III
• Device Catalogue Number: 49.2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2018
• 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
• Patient Age: 68 YR
• Patient Sex: Female