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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 11/24/2021
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 (b)(4) (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). (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)(4) manufacturer report numbers: 3004859032-2022-00001 and 3004859032-2022-00002 for more information.
 
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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
MDR Report Key13388377
MDR Text Key289272048
Report Number1423337-2022-00004
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 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 Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2021
Device Model NumberPA0571
Device Catalogue NumberPA0571
Device Lot Number70113
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2022
Distributor Facility Aware Date12/30/2021
Event Location Hospital
Date Report to Manufacturer01/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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