MAUDE Adverse Event Report: LEICA BIOSYSTEMS NEWCASTLE LTD BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN; BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN - PA0571

Model Number PA0571

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

Patient Problem Insufficient Information (4580)

Event Date 10/10/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, leica biosystems (lbs) received an email from the laboratory supervisor 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.Additional details provided by the laboratory supervisor stated, ".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." patient identifier information was provided for each of the two (2) affected patients.Refer to importer report number, (b)(4) for details of the other patient involved.The leica biosystems melbourne (manufacturer of the bond staining instrument) did not identify any instrument-related root cause for the reported false-positive staining on affected patients: (b)(6).Refer to lbs (b)(4) manufacturer report numbers: 8020030-2022-00009 and 8020030-2022-00010 for more information.The leica biosystems (b)(4) ltd.(manufacturer of the bond¿ ready-to-use primary antibody c-erbb-2 oncoprotein - pa0571) did not identify any reagent-related root cause for the reported false-positive staining on affected patients: (b)(6).Refer to lbs (b)(6) manufacturer report numbers: 3004859032-2022-00001 and 3004859032-2022-00002 for more information.

• Brand Name: BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN
• Type of Device: BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN - PA0571
• Manufacturer (Section D): LEICA BIOSYSTEMS NEWCASTLE LTD; balliol business park west; benton lane; newcastle upon tyne, north tyneside NE12 8EW; UK NE12 8EW
• MDR Report Key: 13387982
• MDR Text Key: 289274876
• Report Number: 1423337-2022-00003
• Device Sequence Number: 1
• Product Code: NJT
• UDI-Device Identifier: 05055331327901
• UDI-Public: 05055331327901
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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 Expiration Date: 05/28/2021
• Device Model Number: PA0571
• Device Catalogue Number: PA0571
• Device Lot Number: 70113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2022
• Distributor Facility Aware Date: 12/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female