OPTIVIEW DAB DETECTION KIT 06396500001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-06-26 for OPTIVIEW DAB DETECTION KIT 06396500001 manufactured by Ventana Medical Systems Inc..

Event Text Entries

[18622310] Customer noticed tissue diagnostic staining intensity issue using optiview with lot c12186. On subsequent tissue stains per the customer, numerous slides were negative. A visual check of the dispensers revealed that the h2o2 dispenser was empty with tests registered as remaining. At this time the customer has indicated one patient is potentially affected. The manufacturer is inquiring as to what the required run controls indicated for this case.
Patient Sequence No: 1, Text Type: D, B5


[18701004] Ventana will continue to remind the customer of required controls and is also investigating the nature of the dispenser seal ("quad seal") from a supplier.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028492-2013-00002
MDR Report Key3197041
Report Source01
Date Received2013-06-26
Date of Report2013-06-26
Date of Event2013-05-28
Date Mfgr Received2013-05-28
Device Manufacturer Date2013-02-01
Date Added to Maude2013-09-19
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 FDA0
Event Location0
Manufacturer ContactRICHARD MOSS
Manufacturer Street1910 EAST INNOVATION PARK DR.
Manufacturer CityTUCSON AZ 857551962
Manufacturer CountryUS
Manufacturer Postal857551962
Manufacturer Phone5208777239
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTIVIEW DAB DETECTION KIT
Generic NameOPTIVIEW DAB
Product CodeNJT
Date Received2013-06-26
Returned To Mfg2013-06-24
Catalog Number06396500001
Lot NumberC12186
ID Number760-700
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-06-26

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