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

Model Number BOND-III

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation of the service record for the instrument showed that a leica biosystems field service engineer was not dispatched to assess the operation and function of the instrument in association with this complaint.The information available does not identify the specific staining run(s) where "*er false positive slides." was reported by the customer.Details of the affected tissue staining run(s) and the instrument logs were not available to the manufacturer.As a result, it was not possible to assess the operation and function of the instrument.Evaluation of the information available by the global technical support manager - applications determined the heat induced epitope retrieval (heir) protocol being used by the complainant is not the recommended heir protocol in the leica estrogen receptor clone 6f11 ready-to-use primary antibody for bond¿ catalog no: pa0151 (7 ml) / pa0009 (30 ml) instructions for use (ifu).The ifu recommends using bond epitope retrieval solution 1 (er1) for 20 minutes and the complainant is using bond epitope retrieval solution 2 (er2) for 30 minutes.The global technical support manager - applications noted "er2 30mins is a much stronger hier than the recommended.This may be a cause for the staining artefact seen." the global technical support manager - applications further noted ".There is not an issue with bond instruments, the customer is using the correct reagents, bond leica slides and other consumables.Other than the issue with the pa0009 er ab there is no issue with other antibodies reported by the customer." the root cause for the "er false positive slides." reported by the complainant was determined by the global technical support manager - applications to be off-label use of the bond epitope retrieval solution.Details of the affected tissue staining run(s) and the instrument logs were not available to the manufacturer.As a result, it was not possible to assess the operation and function of the instrument.However, based on the information available, the global technical support manager - applications determined the instrument functioned as designed in the circumstances reported by the complainant.

Event Description

On (b)(6) 2023, leica biosystems became aware of the following complaint: "*er false positive slides from (b)(6) 2022 to (b)(6) 2023, around [sic] 40 false positive *er slides got noticed by customer.They stained again previous er cases on bond-iii and [instrument] and got very different results.Around [sic] 63% of re-tested slides were false-positive with *er.Since (b)(6) 2023, no more staining issue, for unknown reason." the leica senior application consultant (fas) documented the "*er false positive" reported by the complainant affected (b)(4) patient slides in total, which were stained using five (5) bond-iii instruments at the [customer site].On (b)(6) 2023, the fas documented patients had received treatment based on the initial results received and that "the laboratory is currently sending corrected diagnoses to doctors." on (b)(6) 2023, the fas provided information that although the customer first identified the issue internally in (b)(6), they did not report the issue until (b)(6) 2023 as "it took some time to the customer to realize and investigate (they are still on it) and to identify the staining problem." on (b)(6) 2023, the fas provided further information regarding the circumstances involved in this complaint.The fas documented: "repeatability issues with leica rtu estrogen receptor (*er pa0009) on all 3 customers site [customer sites] with false positive (er2) or false negative (er1)." the fas documented the type(s) of the affected patient samples were "breast biopsies or bigger breast samples", the tissue staining artefact was described as "around [sic] 50 false positive slides noticed" and it was noted the staining artefact affected ".3 labs from the same group (with 3 different pre-analytics).False positive issues from (b)(6) 2022 to (b)(6) 2023 (with nuclear background), it stopped in (b)(6) for unexplained reason !.Today, random false negative issues with er1 30'." on (b)(6) 2023, leica biosystems melbourne received the following information from the local leica senior application consultant: ".2 patients received inappropriate treatment (possibly surgery)." on (b)(6) 2023, leica biosystems melbourne received confirmation from the local leica senior application consultant that ".Around 50 cases." at this site resulted in false positive slides and ".2 patients received an inappropriate treatment because of a misdiagnosis." an identifier, age or date of birth and gender for the two (2) patient cases which ".Received an inappropriate treatment because of a misdiagnosis." has not been provided to leica biosystems.

Event Description

On 05 december 2023, leica biosystems melbourne received the following information from the local leica senior application consultant: "1 patient: probable harm, did not have neoadj [sic] chemo, stopped hormonal therapy, 5 patients: doubt about clinical consequence (partial ttt responses to neoadj [sic] chemo or no neoadj [sic] chemo), 2 patients: hormonal therapy discontinuation".An identifier, age or date of birth and gender for the eight (8) patient cases for which there is ".Possible harm." has not been provided to leica biosystems.

• Brand Name: BOND-III AUTOMATED SLIDE 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: daya currie ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 18018059
• MDR Text Key: 326678749
• Report Number: 8020030-2023-00035
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOND-III
• Device Catalogue Number: 21.2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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