MAUDE Adverse Event Report: LEICA BIOSYSTEMS NEWCASTLE LTD ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿; ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿ - PA0009

Catalog Number PA0009

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2023

Event Type  Injury  

Event Description

A complaint was received on the 3rd of october regarding false positive staining results.Between september 2022 and june 2023, 63 breast cancer cases were retested as the lab suspected false positive estrogen receptor results.The retesting resulted in a change in the interpretation of 40 cases, from positive to negative or at least a decrease in the % positive nuclei in tumour cells.At the time that this complaint was submitted, based on the initial information received regarding a lack of controls and not following the recommended protocol, it was determined that reporting was not required for this issue.Further information was received on the 18th of october 2023 and it was verified that 2 patients received inappropriate treatment (possibly surgery) on the basis of the results however further clarification is yet to be received.This additional information triggered the need for reporting.

Manufacturer Narrative

A manufacturer evaluation has been completed based on the information available thus far.The recommended staining protocol for the estrogen receptor clone 6f11 ready-to-use primary antibody is ihc protocol f, with recommended heat induced epitope retrieval using bond epitope retrieval solution 1 for 20 minutes.The customer information indicates that they are using hier with er2 for 30 minutes instead of the ifu recommendations.The ifu also contains the following information "the clinical interpretation of any positive or negative staining should be evaluated within the context of clinical presentation, morphology and other histopathological criteria.The clinical interpretation of any positive or negative staining should be complemented by morphological studies using proper positive and negative internal and external controls as well as other diagnostic tests." however, information received from the customer confirms that they do not use controls on all sections, only one control per rtu vial, which contains 200 tests.The facts so far, indicate that the estrogen receptor clone 6f11 ready-to-use primary antibody was not used in accordance with the manufacturer recommendations detailed in the instructions for use.Leica biosystems newcastle cannot assess the impact this may or may not have had on the quality of staining of the affected slides.

Manufacturer Narrative

A call is scheduled with the laboratory pathologist to further understand the issue and root cause, further details will be available following this.

Event Description

As of the the 11th of december, additional information was received regarding patient treatment, it was initially suggested that the treatment of two patients was affected by this issue however the additional information received suggests a total of 12 patients may have had treatment as a result of the suspected false positive results.Two additional reports will be logged for two of the patients under the reference (b)(4).The information regarding the other 10 patients is still very limited and is outlined below: (b)(6) hospital: 8 patients in total.I have no precise notion of medical harm.Depending on cpr feedback (not all patients have yet been presented).1 patient: probable harm, did not have neoadj chemo, stopped hormonal therapy.5 patients: doubt about clinical consequence (partial ttt responses to neoadj chemo or no neoadj chemo).2 patients: hormonal therapy discontinuation.(b)(6) hospital: 2 patients: doubt about consequence (geriatric reassessment).Medical affairs are due to have a call with the laboratory pathologist to discuss this case and determine root cause, a follow up will be submitted following the scheduled call.

Manufacturer Narrative

The call between medical affairs and the laboratory pathologists provided no additional information into the root cause or the affect to patient safety.It was confirmed that they no longer use this antibody from leica biosystems and therefore no further investigation can be carried out based on the known information.

Event Description

A call was held on the 11th of january between medical affairs and the laboratory pathologists, no additional information was received regarding patient treatment or safety of the affected patients.The pathologists confirmed that they switched back to dako tests in q4 of 2023 and no longer use pa0009 from leica biosystems.

• Brand Name: ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿
• Type of Device: ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND¿ - PA0009
• Manufacturer (Section D): LEICA BIOSYSTEMS NEWCASTLE LTD; balliol business park west; benton lane; newcastle upon tyne, north tyneside NE12 8EW; UK NE12 8EW
• Manufacturer (Section G): LEICA BIOSYSTEMS NEWCASTLE LTD; balliol business park west; benton lane; newcastle upon tyne, north tyneside NE12 8EW; UK NE12 8EW
• Manufacturer Contact: justine reed ; balliol business park west; benton lane; newcastle upon tyne, north tyneside NE12 -8EW ; UK NE12 8EW
• MDR Report Key: 18088163
• MDR Text Key: 327589168
• Report Number: 3004859032-2023-00001
• Device Sequence Number: 1
• Product Code: MYA
• UDI-Device Identifier: 05055331320421
• UDI-Public: 05055331320421
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Catalogue Number: PA0009
• Device Lot Number: 72692, 72988, 73279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 01/11/2024
• Supplement Dates FDA Received: 01/10/2024; 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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