BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN

    MDR report key: 13387982 · Received January 28, 2022

    Report

    Report Number
    1423337-2022-00003
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    October 10, 2021
    Report Date
    January 28, 2022
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Product Code
    NJT
    UDI-DI
    05055331327901
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362261 BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN BOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN - PA0571 NJT LEICA BIOSYSTEMS NEWCASTLE LTD PA0571 70113 05055331327901

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other