Catalog Number PA0009 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.A call is scheduled with the laboratory pathologist to further understand the issue and root cause, further details will be available following this.
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Event Description
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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 11th of december 2023 and it was verified that 2 patients received inappropriate treatment (possibly surgery) on the basis of the results, this additional information triggered the need for reporting.The information received for patient 2 is outlined below: patient 2 born in 1959 biopsy (b)(6) 2022: non-specific carcinoma grade iii ki-67 50% re- (initially re 50%+) rp- her2 lumpectomy and sentinel lymph nodes: non-specific carcinoma grade iii, pt1bn0 "patient for whom adjuvant chemotherapy was offered but she refused.Harm is suspected because if the doctors had been aware of the rh characteristic, they would have had more arguments to insist on the need to add chemotherapy.The question remains: would the patient have accepted it? " medical affairs are due to have a call with the laboratory pathologist to discuss this case and determine root cause, a follow up report will be submitted following the scheduled call.Please note patient 1 details are outlined in 3004859032-2024-00001, and the initial report prior to patient details being available are detailed in 3004859032-2023-00001.
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Manufacturer Narrative
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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.
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Event Description
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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 patient.The pathologists confirmed that they switched back to dako tests in q4 of 2023 and no longer use pa0009 from leica biosystems.Please note patient 1 details are outlined in 3004859032-2024-00001, and the initial report prior to patient details being available are detailed in 3004859032-2023-00001.
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Search Alerts/Recalls
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