MAUDE MDR 2796736

MDR report key
2796736
Report number
3005248192-2011-00001
Event key
0
Event type
3
Date of event
2010-12-17
Date received
2011-01-12
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
MR DIMITRIS DEMIRTZOGLOU
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
1VP 2000 PROCESSORSTAINER, TISSUE, AUTOMATED, PRODUCT CODE: KEYABBOTT MOLECULAR, INC.KEY02J11-001Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-01-120

Event Narratives#

D

Patient 1

THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. CUSTOMER WAS RUNNING UROVYSION PROTOCOL AND NOTICED THAT BASIN WITH THE PROTEASE HEATED UP TO 69 DEGREES C WHEN THE PROGRAM WAS SET TO 37 DEGREES C. CUSTOMER STOPPED THE VP2000 INSTRUMENT AND REBOOTED. TO TROUBLESHOOT THE VP2000 CUSTOMER FILLED THE HEATED BASINS WITH WATER AND STARTED THE INSTRUMENT WITH THE SAME PROTOCOL. THE INSTRUMENT HEATED UNEXPECTEDLY AND CUSTOMER NOTICED SMOKE BURNING OUT OF THE HEATER MODULE VP2000. CUSTOMER TURNED OFF THE VP2000. CUSTOMER STATED THAT THE VP2000 HEATED BASIN TEMPERATURES WERE NOT BEING CONTROLLED PROPERLY, AND THAT A SMALL AMOUNT OF SMOKE WAS OBSERVED NEAR HEATER BOX #3. FIELD SERVICE NOTED THAT THERE WAS DRIED AND CRYSTALLIZED REAGENT UNDER HEATER BOX #1, AND THAT THIS REAGENT HAD SLOWLY ADVANCED TO THE HEATER MODULE ASSY. CONTROL BOARD ((B)(4)). DAMAGE WAS OBSERVED ON THE HEATER MODULE ASSEMBLY, CONTROL BOARD AROUND THE HEATER BOX POWER CONNECTORS, AND IT WAS DETERMINED THAT THE CRYSTALLIZED REAGENT HAD "SHORTED" THE HEATER BOX POWER CONNECTIONS. THE CIRCUIT BREAKER (INSTRUMENT ON/OFF SWITCH) WAS FOUND IN THE "OFF" POSITION, INDICATING THAT THE CIRCUIT BREAKER TRIPPED WHEN THE SHORT OCCURRED. FIELD SERVICE REPLACED THE HEATER MODULE ASSEMBLY TO RESOLVE THIS ISSUE. NO INJURY WAS REPORTED.