06679072001 790-4794

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for 06679072001 790-4794 manufactured by Ventana Medical Systems Inc.

Event Text Entries

[102715597] The alk package insert (b)(4) and interpretation guide (b)(4) mandate the use of system controls run with all patient samples. The package insert specifically calls out excessive non-specific background staining of glandular epithelial cells, muscle, or lymphoid tissue that interferes with scoring as unacceptable and instructs users that if the positive or negative tissue controls fail to demonstrate appropriate staining or demonstrate a change in clinical diagnostic interpretation, any results with the test specimens should be considered invalid.
Patient Sequence No: 1, Text Type: N, H10


[102715598] Allegation of unacceptable staining (commonly referred to as background, non-specific, and/or overstaining) with product alk (d5f3) contributed to a multiple repeat runs which contributed to the tissue sample being exhausted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028492-2018-00006
MDR Report Key7346049
Date Received2018-03-16
Date of Report2018-03-16
Date of Event2018-02-14
Date Mfgr Received2018-02-15
Date Added to Maude2018-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA TIM GIBLIN
Manufacturer Street1910 EAST INNOVATION PARK DR NA
Manufacturer CityTUSCON AZ 85755
Manufacturer CountryUS
Manufacturer Postal85755
Manufacturer Phone5208777035
Manufacturer G1VENTANA MEDICAL SYSTEMS INC
Manufacturer Street1910 E INNOVATION PARK DR
Manufacturer CityTUCSON AZ 857551962
Manufacturer CountryUS
Manufacturer Postal Code857551962
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Generic NameALK
Product CodePKW
Date Received2018-03-16
Model Number06679072001
Catalog Number790-4794
Lot NumberG10367
ID NumberNA
Device Expiration Date2019-01-06
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS INC
Manufacturer Address1910 E INNOVATION PARK DR NA TUCSON AZ 857551962 US 857551962


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-16

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