FDA.reportPublic FDA data

MAUDE MDR 6761675

MDR report key
6761675
Report number
2517506-2017-00620
Event key
0
Event type
3
Date of event
2017-07-08
Date received
2017-08-02
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARGARITA KARAN
Address
511 BENEDICT AVENUE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0DIMENSION VISTA1500DIMENSION VISTA1500SIEMENS HEALTHCARE DIAGNOSTICS INC.CHSDIMENSION VISTA1500N N
1DIMENSION VISTA1500DIMENSION VISTA1500SIEMENS HEALTHCARE DIAGNOSTICS INC.JJEDIMENSION VISTA1500N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-020

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SUPPORT CENTER (TSC) TO REPORT THE DISCORDANT CARBON DIOXIDE (CO2) RESULTS. THE CUSTOMER RAN QUALITY CONTROL (QC), WHICH WAS LOW. THE CUSTOMER TRIED TO ALIGN SERVER 2 PROBES. THE CUSTOMER FOUND THAT THE REAGENT PROBE 4 (R4) WAS FAILING ALIGNMENT. THE TSC ASKED THE CUSTOMER TO INSPECT THE R4 AND, THE PROBE WAS STRAIGHT. THE CUSTOMER RESEATED THE PROBE, CLEANED THE BEARING RAILS AND FOUND THE R4 STILL FAILING. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE ALIGNED THE R4 ARM REPEATEDLY BUT IT FAILED AT BASEPLATE. THE CSE REPLACED VERTICAL AND HORIZONTAL BELTS AND HORIZONTAL MOTOR, ALIGNED R4 AGAIN, WHICH PASSED. THE CSE BROUGHT ANALYZER BACK UP AND RAN SERVER 2 SERVICE METHODS (SVMTS). THE CSE FOUND THAT THE SAMPLE PROBE 2 (S2) MIXER IS NOT MIXING. THE CSE DISABLED SERVER 2 AND MOVED CO2 TO SERVER 3. THE CSE REPLACED S2 MIXER. THE CSE RAN SVMTS, MIXER DIAGNOSTIC TEST, CHECK1 AND QUALITY CONTROL (QC), WHICH PASSED. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE DATA RELATED TO THE EVENT. HSC CONCLUDES THE CAUSE OF THE ISSUE IS DUE TO A FAILING SAMPLE MIXER FOR SERVER 2 THAT WAS RESOLVED WITH REPLACEMENT OF THE SAMPLE MIXER ON SERVER 2. THE CAUSE OF THE DISCORDANT CARBON DIOXIDE RESULTS IS DUE TO FAILING SAMPLE MIXER. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

D

Patient 1

DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON NINE PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, AND RECOVERED HIGHER. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2 RESULTS.