FDA.reportPublic FDA data

MAUDE MDR 3601542

MDR report key
3601542
Report number
1226181-2014-00050
Event key
0
Event type
3
Date of event
2014-01-01
Date received
2014-01-31
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
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
1DIMENSION VISTA CLINICAL CHEMISTRY SYSTEMCLINICAL CHEMISTRY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.MZVDIMENSION VISTA 500N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-310

Event Narratives#

D

Patient 1

A DISCORDANT, FALSELY ELEVATED POTASSIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND THE SAME INSTRUMENT, RESULTING LOWER ON BOTH. ADDITIONAL RESULTS WERE PROVIDED FOR A SAMPLE THAT RESULTED HIGH ON THE DIMENSION VISTA 500 INSTRUMENT AND RESULTED LOWER UPON REPEAT TESTING, BUT IT IS UNKNOWN IF THE SAMPLE WAS FOR THE SAME PATIENT OR A DIFFERENT PATIENT OR WHICH INSTRUMENT(S) THE SAMPLE WAS REPEATED ON. IT IS UNKNOWN IF ANY REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED POTASSIUM RESULT.

N

Patient 1

A SIEMENS GLOBAL PRODUCT SUPPORT SPECIALIST EVALUATED THE INSTRUMENT DATA AND DID NOT FIND A MALFUNCTION. IT WAS ALSO DISCOVERED THAT THE OTHER SAMPLES TESTED WITHIN THE SAME TIME FRAME HAD RESULTED AS EXPECTED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED POTASSIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.