FDA.reportPublic FDA data

MAUDE MDR 7103748

MDR report key
7103748
Report number
2517506-2017-00865
Event key
0
Event type
3
Date of event
2017-11-04
Date received
2017-12-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAMES MORGERA
Address
500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US
Phone
302-302-3026
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIMENSION VISTA?DIMENSION VISTA? DIGXN LOCI DIGOXIN FLEX? REAGENT CARTRIDGESIEMENS HEALTHCARE DIAGNOSTICS INCKXTK6435 SMN1048892717103BCN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-110

Event Narratives#

N

Patient 1

MDR 2517506-2017-00861, MDR 2517506-2017-00862, MDR 2517506-2017-00863, MDR 2517506-2017-00864, MDR 2517506-2017-00866, MDR 2517506-2017-00867, MDR 2517506-2017-00868, MDR 2517506-2017-00869, MDR 2517506- 2017-00870, MDR 2517506-2017-00871, MDR 2517506-2017-00872, MDR 2517506-2017-00873, MDR 2517506-2017-00874, MDR 2517506-2017-00875 WERE ALSO FILED FOR THE SAME CUSTOMER INQUIRY. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER FOR THE DISCORDANT ELEVATED DIGOXIN RESULT ON THE DIMENSION VISTA INSTRUMENT. QUALITY CONTROL WAS WITHIN SPECIFICATION DURING TESTING. SIEMENS IS INVESTIGATING THE INCIDENT.

D

Patient 1

A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT AND HIGH RESULTS WERE OBTAINED. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.