HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY 790-2991 05278368001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-22 for HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY 790-2991 05278368001 manufactured by Ventana Medical Systems, Inc..

Event Text Entries

[1315094] The ventana sales representative called to report that during a demonstration for lot# 680957 of pathway her2 (4b5), the customer observed lighter staining compared to other lots. No report of pt harm or pt care being adversely affected.
Patient Sequence No: 1, Text Type: D, B5


[8498246] This antibody is intended for in vitro diagnostic use. Ventana medical systems, inc's (ventana) pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody (pathway her2 (4b5)) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of her2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer pts for whom herceptin treatment is considered. Light staining with lot# 680957 is detectable if appropriate low-expressing/low-level controls are utilized. Pathologists who are familiar with the usual appearance and intensity of their control tissues may recognize the problem as lighter than usual control tissue staining. The test is designed to be read by a pathologist who has knowledge of proper interpretation of her2 scoring as well as the factors that can influence scores (i. E. Retrieval, tissue fixation, instrument variability etc. ). Laboratories are instructed to use their own controls and pathologists are similar with the performance of these controls in their laboratory. Investigation confirmed lot# 680957 stained lighter when compared to other reference lots of pathway her2 (4b5). The light staining could result in scores of up to a full point reduction in the clinical score, which could prevent further eval and allow pts to go untreated. This issue of light staining is limited to lot# 680957 and there have been no reported cases of pt diagnosis being adversely affected from this issue. Ventana medical systems has notified all customers who have received lot# 680957 and this lot has been recalled.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028492-2009-00004
MDR Report Key1574334
Report Source05,06
Date Received2009-12-22
Date of Report2009-09-01
Date of Event2009-09-01
Date Mfgr Received2009-09-01
Device Manufacturer Date2009-07-01
Date Added to Maude2010-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTWEED HANUSEK
Manufacturer Street1910 EAST INNOVATION PARK DR.
Manufacturer CityTUCSON AZ 85755
Manufacturer CountryUS
Manufacturer Postal85755
Manufacturer Phone5202294130
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2028492-09/08-09-001-R
Event Type3
Type of Report3

Device Details

Brand NameHER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY
Generic NamePATHWAY HER2 (4B5)
Product CodeMVC
Date Received2009-12-22
Returned To Mfg2009-10-06
Model Number790-2991
Catalog Number05278368001
Lot Number680957
ID NumberNA
Device Expiration Date2011-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS, INC.
Manufacturer Address1910 EAST INNOVATION PARK DR. TUCSON AZ 85755 US 85755


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-22

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