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LEICA BIOSYSTEMS NEWCASTLE LTD ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND; IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR
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| Model Number PA0151 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Insufficient Information (4580)
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| Event Date 05/25/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The instrument logs provided for manufacturer evaluation included the run events and batch details for staining of the affected biopsies performed by the complainant and the repeat staining, service events for the period (b)(6) 2020 and (b)(6) 2021 and the protocol report for "ihc protocol f extra wash".Manufacturer evaluation of the information available showed that: the information available indicates that the initial staining result was positive and the second (repeat) staining result was negative for the following samples (the "affected biopsies"): patient 1 (female - (b)(6)).Biopsy id: (b)(6).Reported: weak positive (4/8) - stained on (b)(6) 2020.Repeat reported: negative (2/8) - stained on (b)(6) 2021.Patient 2 (female - (b)(6)).Biopsy, id:(b)(6) (although initially reported as (b)(4), the logs provided indicate the id was actually (b)(6)).Reported: positive (6/8) - stained on (b)(6) 2020.Repeat (id is er test) reported: negative 2/8 - stained on (b)(6) 2021.Initial staining of the affected biopsies was performed using leica biosystems "estrogen receptor clone 6f11" (er 6f11) with heat induced epitope retrieval (hier) using epitope retrieval solution 1 for 40 minutes (er1 40 min) and the "ihc protocol f extra wash" staining protocol.Repeat staining of the affected biopsies was performed using er 6f11 and "ihc protocol f extra wash", with epitope retrieval solution 2 for 20 minutes.Note: the instructions for use (ifu) of er 6f11 indicate: "the recommended staining protocol for estrogen receptor clone 6f11 [.] primary antibody for bond" is ihc protocol f.Heat induced epitope retrieval is recommended using bond epitope retrieval solution 1 for 20 minutes." the er 6f11 ifu contain the following specific advice: "use a non-specific negative reagent control in place of the primary antibody with a section of each patient specimen to evaluate non-specific staining and allow better interpretation of specific staining at the antigen site." information regarding the use and the outcome of a negative reagent control was not available.The "ihc protocol f extra wash" protocol is in accordance with the er 6f11 ifu.Information available suggests that all slides had both positive and negative tissue control, which stained as expected in both the initial and the repeat staining.Regarding the examination of the stained patient tissue samples, the er 6f11 ifu contains the following information in the interpretation of staining entitled patient tissue section: "as with any immunohistochemical test, a negative result means that the antigen was not detected, not that the antigen was absent in the cells/tissue assayed.If necessary, use a panel of antibodies to identify false-negative reactions." the root cause of the staining discrepancy reported by the complainant between the initial and repeat staining of the affected biopsies could not be determined from the information available.Manufacturer evaluation of the relevant instrument logs showed that: a slide prepared from biopsy id (b)(6) was first stained in run 5714 on slide staining assembly (ssa2), starting at 01:00am on (b)(6) 2020 and completing at 04:14am on (b)(6) 2020.The ssa was unlocked to retrieve the slides at 07:42 on (b)(6) 2020, which would have incurred additional dispenses of deionized water every 15 minutes for 3 hours and 28 minutes.Another slide prepared from biopsy id (b)(6) was stained in run 7597 on slide staining assembly (ssa3), starting at 09:52am on (b)(6) 2021 and completing at 11:50am on (b)(6) 2021.A slide prepared from biopsy id (b)(6) was stained in run 6866 on slide staining assembly (ssa3), starting at 08:25am on (b)(6) 2020 and completing at 11:05am on (b)(6) 2020.Another slide prepared from biopsy id (b)(6) was stained in run 7476 on slide staining assembly (ssa1), starting at 12:28pm on (b)(6) 2021 and completing at 14:51pm on (b)(6) 2021.Review of the events recorded in the logs found that the instrument functioned as designed on (b)(6) 2020, (b)(6) 2020, (b)(6) 2021 and (b)(6) 2021 during processing of the slides prepared from the affected biopsies.Manufacturer evaluation of the information available did not identify any instrument-related root cause for the reported "false positive" estrogen receptor clone 6f11 staining of biopsy samples from two (2) patients following processing using bond-iii automated stainer serial number (b)(4).
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Event Description
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On (b)(6) 2021, the complainant reported "false positive staining with er rtu antibody" to leica biosystems.The following further information was documented by the leica representative, which was reported by the complainant, in relation to the event: "we have had a problem identified by the rvi of two cases where we have stained the patients breast tru-cut sections and they have been diagnosed as er positive but when the rvi re-stained the same cases they were er negative.We have had one of the blocks returned from the rvi and re-stained it with a different batch number of er and it was negative.The false positive staining has affected patient treatment".The complainant further detailed that: ".The false positive staining occurred in (b)(6) 2020 and then again in (b)(6) 2020." on 11 june 2021, leica biosystems (b)(4) received the following additional information, which was provided to the leica field support scientist-(b)(4) by the complainant: "please see below for details of er staining and results carried out at (b)(6) infirmary.All positive tests from (b)(6) were originally repeated at rvi on ventana where they were reported negative.They were then repeated at (b)(6), again details are below.Hsl have also repeated all 3 positive biopsies and they were reported negative.All repeats were cut fresh from the same blocks.All tests at (b)(6) were cut fresh and baked in the same oven for same length of time.Control sections are not cut fresh but would be no more than one week.Good positive and negative control on all slides.Antigen retrieval at (b)(6) used is er1(40) with protocol f + extra wash.Service from (b)(6) was pulled in march, all er requests now going to rvi.(b)(6), lab manager, unsure of the affect had on either patient but may have influenced treatment.Patient 1 female: (b)(6).1st biopsy, id: (b)(6), (b)(6) 2020.Reported: weak positive (4/8).Repeat reported: negative (2/8).1st wle, id: (b)(6), (b)(6) 2020.Reported: negative.2nd biopsy, id: (b)(6), (b)(6) 2020.Reported: negative (0/8).2nd wle, id: (b)(6), (b)(6) 2020.Reported: negative (0/8).3rd biopsy, id: (b)(6), (b)(6) 2020.Reported: positive (5/8).Repeat: positive (6/8).3 further slides from 3rd biopsy repeated ((b)(6) 2021) with different lot of er: 67833 and different antigen retrieval method.All positive.1 slide on each ssa.Staining intensity significantly varied between each slide.Patient 2 female: (b)(6).1st biopsy, id: (b)(6), (b)(6) 2020.Reported: positive (6/8) (note: (b)(6) (lab manager) and myself looked at this and would have scored it as weak positive 4/8 when comparing with other slides) repeat (id is er test) reported: negative 2/8" on (b)(6) 2021, leica biosystems (b)(4) received the following additional information, which was provided to the leica field support scientist-(b)(4) by the complainant: "all slides stained at (b)(6) had a positive and negative control on the slide.These all stained as expected, with consistent positive and negative staining.All patient tests and repeats received the er1(40min) antigen retrieval, other than 3 slides stained on (b)(6) where the lab wanted to test if a different antigen retrieval method would change the results (tests were still positive).The 'run records' mentioned by the customer were internal records, not reports from bond.This was because i had asked what caused the repeat testing initially and the customer said she could not find the records why.(b)(6) do not do pr staining, they said rvi reported patient 1 as negative on all 5 specimens and that pr had not been done on patient 2.I have asked the lab manager at (b)(6) on multiple occasions if she can find out/share with us the affect had on patient treatment but have had no information from her.I have managed to get a contact from her for the reporting pathologist, i have shared this with qa in (b)(4) and the plan is to have a clinician from leica reach out to them.I spoke with the lab manager last week and (b)(6) have just sent all slides and blocks to hsl for re-testing and investigation.They are going to repeat all tests on their bond iii with the leica er rtu.They are not expecting feedback before 25th june, but i will check in with the customer mid-week." as at (b)(6) 2021, leica biosystems (b)(4) has not received further information in relation to either the impact to patient treatment or the age of the affected patients.Refer to mfr.Report #3004859-2021-00001 for specific details of the other patient involved.
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Event Description
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On (b)(6) 2021, the complainant reported "false positive staining with er rtu antibody" to leica biosystems.The following further information was documented by the leica representative, which was reported by the complainant, in relation to the event: "we have had a problem identified by the rvi of two cases where we have stained the patients breast tru-cut sections and they have been diagnosed as er positive but when the rvi re-stained the same cases they were er negative.We have had one of the blocks returned from the rvi and re-stained it with a different batch number of er and it was negative.The false positive staining has affected patient treatment".The complainant further detailed that: ".The false positive staining occurred in (b)(6) 2020 and then again in (b)(6) 2020." on (b)(6) 2021, leica biosystems (b)(6) received the following additional information, which was provided to the leica field support scientist-scotland by the complainant: "please see below for details of er staining and results carried out at (b)(6) infirmary.All positive tests from (b)(6) were originally repeated at rvi on ventana where they were reported negative.They were then repeated at (b)(6) again details are below.Hsl have also repeated all 3 positive biopsies and they were reported negative.All repeats were cut fresh from the same blocks.All tests at (b)(6) were cut fresh and baked in the same oven for same length of time.Control sections are not cut fresh but would be no more than one week.Good positive and negative control on all slides.Antigen retrieval at (b)(6) used is er1(40) with protocol f + extra wash.Service from (b)(6) was pulled in (b)(6), all er requests now going to rvi.(b)(6), lab manager, unsure of the affect had on either patient but may have influenced treatment.Patient 1 female: (b)(6) 1st biopsy, id: (b)(6) (b)(6) 2020 reported: weak positive (4/8) repeat reported: negative (2/8) 1st wle, id: (b)(6), (b)(6) 2020 reported: negative 2nd biopsy, id: (b)(6), (b)(6) 2020 reported: negative (0/8) 2nd wle, id: (b)(6), (b)(6) 2020 reported: negative (0/8) 3rd biopsy, id: (b)(6) , (b)(6) 2020 reported: positive (5/8) repeat: positive (6/8) 3 further slides from 3rd biopsy repeated ((b)(6) 2021) with different lot of er: (b)(6) and different antigen retrieval method.All positive.1 slide on each ssa.Staining intensity significantly varied between each slide.Patient 2 female: (b)(6) 1st biopsy, id:(b)(6), (b)(6) 2020 reported: positive (6/8) (note: (b)(6) (lab manager) and myself looked at this and would have scored it as weak positive 4/8 when comparing with other slides) repeat (id is er test) reported: negative 2/8" on (b)(6) 2021, leica biosystems newcastle received the following additional information, which was provided to the leica field support scientist-scotland by the complainant: "all slides stained at (b)(6) had a positive and negative control on the slide.These all stained as expected, with consistent positive and negative staining.All patient tests and repeats received the er1(40min) antigen retrieval, other than 3 slides stained on (b)(6) where the lab wanted to test if a different antigen retrieval method would change the results (tests were still positive).The 'run records' mentioned by the customer were internal records, not reports from bond.This was because i had asked what caused the repeat testing initially and the customer said she could not find the records why.(b)(6) do not do pr staining, they said rvi reported patient 1 as negative on all 5 specimens and that pr had not been done on patient 2.I have asked the lab manager at (b)(6) on multiple occasions if she can find out/share with us the affect had on patient treatment but have had no information from her.I have managed to get a contact from her for the reporting pathologist, i have shared this with qa in newcastle and the plan is to have a clinician from leica reach out to them.I spoke with the lab manager last week and (b)(6) have just sent all slides and blocks to hsl for re-testing and investigation.They are going to repeat all tests on their bond iii with the leica er rtu.They are not expecting feedback before (b)(6), but i will check in with the customer mid-week." as of (b)(6) 2021, leica biosystems newcastle has not received further information in relation to either the impact to patient treatment or the age of the affected patients.As of (b)(6) 2021, leica biosystems newcastle has not received further information in relation to either the impact to patient treatment or further demographics of the patient.Three attempts have been made to discuss with health care professionals that initially raised the issue to leica biosystems newcastle.The health care professionals have not been able to provide any further updates and have failed to meet with leica staff to discuss further.No further progress can be made with this issue at this time.Leica biosystems newcastle is requesting closure of this incident.If further information is received at a later date and warrants the reopening of this case.We will contact the fda immediately.Refer to mfr.Report #3004859-2021-00001 for specific details of the other patient involved.
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Manufacturer Narrative
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The instrument logs provided for manufacturer evaluation included the run events and batch details for staining of the affected biopsies performed by the complainant and the repeat staining, service events for the period (b)(6) 2020 and (b)(6)2021 and the protocol report for "ihc protocol f extra wash".Manufacturer evaluation of the information available showed that: - the information available indicates that the initial staining result was positive and the second (repeat) staining result was negative for the following samples (the "affected biopsies"): patient 1 (female - (b)(6)) biopsy id: (b)(6) reported: weak positive (4/8) - stained on (b)(6) 2020 repeat reported: negative (2/8) - stained on (b)(6) 2021 patient 2 (female - (b)(6)) biopsy, id:(b)(6) (although initially reported as (b)(6), the logs provided indicate the id was actually (b)(6)) reported: positive (6/8) - stained on (b)(6) 2020 repeat (id is er test) reported: negative 2/8 - stained on (b)(6) 2021 - initial staining of the affected biopsies was performed using leica biosystems "estrogen receptor clone 6f11" (er 6f11) with heat induced epitope retrieval (hier) using epitope retrieval solution 1 for 40 minutes (er1 40 min) and the "ihc protocol f extra wash" staining protocol.- repeat staining of the affected biopsies was performed using er 6f11 and "ihc protocol f extra wash", with epitope retrieval solution 2 for 20 minutes.Note: the instructions for use (ifu) of er 6f11 indicate: "the recommended staining protocol for estrogen receptor clone 6f11 [.] primary antibody for bond¿ is ihc protocol f.Heat induced epitope retrieval is recommended using bond epitope retrieval solution 1 for 20 minutes." the er 6f11 ifu contain the following specific advice: "use a non-specific negative reagent control in place of the primary antibody with a section of each patient specimen to evaluate non-specific staining and allow better interpretation of specific staining at the antigen site." information regarding the use and the outcome of a negative reagent control was not available.- the "ihc protocol f extra wash" protocol is in accordance with the er 6f11 ifu.- information available suggests that all slides had both positive and negative tissue control, which stained as expected in both the initial and the repeat staining.- regarding the examination of the stained patient tissue samples, the er 6f11 ifu contains the following information in the interpretation of staining entitled patient tissue section: "as with any immunohistochemical test, a negative result means that the antigen was not detected, not that the antigen was absent in the cells/tissue assayed.If necessary, use a panel of antibodies to identify false-negative reactions." the root cause of the staining discrepancy reported by the complainant between the initial and repeat staining of the affected biopsies could not be determined from the information available.Manufacturer evaluation of the relevant instrument logs showed that: - a slide prepared from biopsy id (b)(6) was first stained in run 5714 on slide staining assembly (ssa2), starting at 01:00am on (b)(6) 2020 and completing at 04:14am on (b)(6) 2020.The ssa was unlocked to retrieve the slides at 07:42 on (b)(6) 2020, which would have incurred additional dispenses of deionized water every 15 minutes for 3 hours and 28 minutes.- another slide prepared from biopsy id (b)(6) was stained in run (b)(6) on slide staining assembly (ssa3), starting at 09:52am on (b)(6) 2021 and completing at 11:50am on (b)(6) 2021.- a slide prepared from biopsy id (b)(6) was stained in run (b)(6) on slide staining assembly (ssa3), starting at 08:25am on (b)(6) 2020 and completing at 11:05am on (b)(6) 2020.- another slide prepared from biopsy id (b)(6) was stained in run (b)(6) on slide staining assembly (ssa1), starting at 12:28pm on (b)(6) 2021 and completing at 14:51pm on (b)(6) 2021.Review of the events recorded in the logs found that the instrument functioned as designed on (b)(6) 2020, (b)(6) 2020, (b)(6)2021 and (b)(6) 2021 during processing of the slides prepared from the affected biopsies.Manufacturer evaluation of the information available did not identify any instrument-related root cause for the reported "false positive" estrogen receptor clone 6f11 staining of biopsy samples from two (2) patients following processing using bond-iii automated stainer serial number (b)(6).
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