06396500001 760-700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-18 for 06396500001 760-700 manufactured by Ventana Medical Systems Inc.

Event Text Entries

[108728455] Sticking and leaking dispensers required repeat runs. The repeat runs exhausted the patient tissue sample and required a re-biopsy before retesting could be completed. This is the initial and final report.
Patient Sequence No: 1, Text Type: N, H10


[108728456] Failed runs due to sticking or leaky dispensers required repeating the runs and led to tissue sample of patient being exhausted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028492-2018-00010
MDR Report Key7527123
Date Received2018-05-18
Date of Report2018-05-18
Date of Event2018-04-20
Date Mfgr Received2018-04-20
Date Added to Maude2018-05-18
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 NameOPTIVIEW DAB
Product CodeNJT
Date Received2018-05-18
Model Number06396500001
Catalog Number760-700
Lot NumberE02544
ID NumberNA
Device Expiration Date2019-06-27
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
101. Other 2018-05-18

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