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U.S. Department of Health and Human Services

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

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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 Back to Search Results
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  
Manufacturer Narrative
Manufacturer evaluation of the information available, which includes the relevant run events and service events, indicates that the two (2) slides for which false positive staining was reported (hereafter referred to as the "affected slides") were: slide id: (b)(6) with case id: (b)(4), which was stained at slide (b)(4) on slide staining assembly (ssa) 1 in run 20651 executed on (b)(6) 2021, and slide id: (b)(6) with case id: (b)(4), which was stained at slide position 3 on ssa 1 in run 21164 executed on (b)(6) 2021. Staining of both affected slides was performed using bond-iii automated stainer serial number (b)(4); and both run 20651 and 21164 completed successfully with no recorded event(s) to suggest any malfunction(s) of the instrument. Additionally, slide id: (b)(6) was stained in run 20651 together with two (2) other slides with bond slide ids (b)(6) using the same staining protocol and the same reagents with no problem regarding the quality of staining reported to the manufacturer for slides with slide ids: (b)(6); and slide id: (b)(6)was stained in run 21164 together with three (3) other slides with bond slide ids: (b)(6) using the same staining protocol and the same reagents, with no problem regarding the quality of staining reported to the manufacturer for slides with slide ids: (b)(6). The information available also indicates that staining of both of the affected slides was performed using on-the-instrument factory default *dewax protocol, with factory default heat induced epitope retrieval (her) protocol *her 40 min and er1/ and custom staining protocol "her2 (b)(6)" with leica biosystems bond ready to use primary antibody *c-erbb-2 oncoprotein (clone cb11) catalog no: pa0571 and the bond polymer refine detection kit. The class i, bond ready-to-use primary antibody c-erbb-2 oncoprotein (cb11) instructions for use contain the following information: "the clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist," and "c-erbb-2 oncoprotein (cb11) primary antibody was developed for use on the automated bond system (includes leica bondmax system and leica bond-iii system) in combination with bond polymer refine detection. The recommended staining protocol for c-erbb-2 oncoprotein (cb11) primary antibody is ihc protocol f. Heat induced epitope retrieval is recommended. Using bond epitope retrieval solution 2 for 20 minutes. " the facts indicate that the bond ready-to-use primary antibody c-erbb-2 oncoprotein (cb11) was not used in accordance with the manufacturer recommendations detailed in the instructions for use (ifu), because the available information indicates that the affected slides were stained using bond epitope retrieval solution 1 for 40 minutes rather than the recommended bond epitope retrieval solution 2 for 20 minutes; and the custom "her2 (b)(6)" protocol used for staining of the affected slides is not identical to the recommended ihc protocol f. Leica biosystems newcastle cannot assess the impact this may or may not have had on the quality of staining of the affected slides. The information available suggests that run 20651 and run 21164 had both positive and negative tissue controls run. However, information available does not indicate the type of control tissue used and whether they were placed on the same slides as the tissue for case id: (b)(4), in line with the instrument manufacturer recommendations 6. 2 of the leica biosystems bond system user manual for bond systems running bond 6. 0 software (for use only in the usa) entitled "working with controls," the run events for run 20651 and run 21164 do not suggest that slides with control tissue were placed on the same ssa as bond slide id: (b)(6) with case id: (b)(4) and bond slide id: (b)(6) for case id: (b)(4). Manufacturer evaluation of the information available did not identify any instrument-or reagent related root cause for the reported false positive staining of bond slide id: (b)(6) with case id: (b)(4) and bond slide id: (b)(6) for case id: (b)(4), following processing using bond-iii automated stainer serial number (b)(4). The root cause of the false positive staining reported by the complainant on 30 (b)(6) 2021 could not be determined from the information available.
 
Event Description
On (b)(6) 2021 at 1:39pm eastern i received an email from (b)(6) lab supervisor stating 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. Thus bringing us to current status. Refer to report 3004859032 2022 00002 for details of the other patient involved.
 
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Brand NameBOND¿ READY-TO-USE PRIMARY ANTIBODY C-ERBB-2 ONCOPROTEIN
Type of DeviceBOND¿ 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
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 Key13384756
MDR Text Key289318000
Report Number3004859032-2022-00001
Device Sequence Number1
Product Code NJT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/16/2022
Device Model NumberPA0571
Device Catalogue NumberPA0571
Device Lot Number69751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/28/2022 Patient Sequence Number: 1
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