FDA.reportPublic FDA data

MAUDE MDR 6490460

MDR report key
6490460
Report number
2517506-2017-00390
Event key
0
Event type
3
Date of event
2017-03-20
Date received
2017-04-13
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
CASSANDRA KOCSIS
Address
511 BENEDICT AVE 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 VISTA 500CLINICAL CHEMISTRY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.JGYDIMENSION VISTA 500N N
1DIMENSION VISTA 500CLINICAL CHEMISTRY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.JJEDIMENSION VISTA 500N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-130

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE CCC SPECIALIST DETERMINED THAT THE CUSTOMER HAD REPLACED THE FILTER OF THE WATER PURIFICATION MODULE (WPM) PRIOR TO THE EVENT OCCURRENCE. THE CUSTOMER CALIBRATED THE ASSAY SUSPECTING THAT THE WATER MAY HAVE CAUSED THE PROBLEM. THE CCC SPECIALIST DIALED INTO THE SYSTEM REMOTELY AND ENSURED THAT THE FILTERS WERE INSTALLED PROPERLY. THE CCC SPECIALIST THEN EMPTIED AND REFILLED WPM TO ENSURE THAT THERE WAS NO CONTAMINATION. UPON THE CCC SPECIALIST'S INSTRUCTIONS, THE CUSTOMER RECALIBRATED THE ASSAY AND THE RESULTS WERE ACCEPTABLE. THE CCC SPECIALIST REVIEWED THE CALIBRATION DATA AND VERIFIED THAT THE SIGNAL READINGS WERE WITHIN SPECIFICATIONS POST RECALIBRATION. QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. THE CCC SPECIALIST STATED THAT THE ISSUE OCCURRED WHEN THE CUSTOMER REPLACED THE FILTER ON THE WPM WITHOUT THOROUGHLY RINSING IT. THE FILTERS CONTAIN GLYCEROL, WHICH CAUSED THE WATER IN THE SYSTEM TO BECOME CONTAMINATED WITH GLYCEROL, RESULTING IN ELEVATED TRIG RESULTS. THE CCC ALSO STATED THE RECALIBRATION OF THE ASSAY BY THE CUSTOMER ON THE SUSPICION THAT THE WATER MAY HAVE CAUSED THE PROBLEM FURTHER CONTRIBUTED TO THE ISSUE. EMPTYING AND REFILLING THE WPM AND THEN RECALIBRATING THE ASSAY AFTER REFILLING THE WATER RESOLVED THE ISSUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

DISCORDANT, FALSELY ELEVATED TRIGLYCERIDE (TRIG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER THAN THE INITIAL RESULTS HOWEVER, STILL ELEVATED. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S), EXCEPT FOR ONE PATIENT SAMPLE. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING DIFFERENT FROM THE RESULTS OBTAINED ON THE ORIGINAL DIMENSION VISTA INSTRUMENT (S/N: (B)(4)) AND MATCHING THE CLINICAL PICTURE OF THE PATIENTS. THE RESULTS OBTAINED ON THE ALTERNATE DIMENSION VISTA WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED TRIG RESULTS.