FDA.reportPublic FDA data

MAUDE MDR 3588339

MDR report key
3588339
Report number
3005248192-2013-00016
Event key
0
Event type
3
Date of event
2013-11-22
Date received
2014-01-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JEENE LEETE
Address
1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US
Phone
224-224-2243
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDESMICROSCOPIC CONTROL SLIDES UED IN FISH TESTINGABBOTT MOLECULAR, INC.NSD02J27-11448596N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-220

Event Narratives#

D

Patient 1

THE PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES ARE NON-HYBRIDIZED SLIDES PREPARED WITH CULTURED NORMAL MALE LYMPHOBLAST CELLS AND CULTURED BLADDER CANCER CELL LINES. EACH CONTROL SLIDE CONSISTS OF TWO SEPARATE TARGET AREAS IN WHICH EACH OF THE DIFFERENT CELL TYPES HAVE BEEN APPLIED. THE CELL LINES ARE HARVESTED, FIXED IN SUSPENSION MEDIUM, AND APPLIED TO THE GLASS MICROSCOPE SLIDES IN A METHOD OPTIMAL FOR FISH (FLUORESCENCE IN SITU HYBRIDIZATION). A CUSTOMER REPORTED RECEIVING A BROKEN PROBECHEK UROVYSION CONTROL SLIDE. THERE WAS NO REPORT OF INJURY. THE PROBECHEK UROVYSION CONTROL SLIDES PACKAGE INSERT INDICATES THAT THESE SLIDES CONTAIN HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. IF THE ISSUE OF CUSTOMER RECEIVING BROKEN PROBECHEK SLIDES WERE TO RECUR, IT IS POSSIBLE THAT CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE. THEREFORE, RECURRENCE OF THIS ISSUE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.