FDA.reportPublic FDA data

MAUDE MDR 7423337

MDR report key
7423337
Report number
2517506-2018-00222
Event key
0
Event type
3
Date of event
2018-02-28
Date received
2018-04-11
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? TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX? REAGENT CARTRIDGESIEMENS HEALTHCARE DIAGNOSTICS INC.MTFK6451 SMN 1044509017314BDN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-110

Event Narratives#

N

Patient 1

MDRS 2517506-2018-00219, 2517506-2018-00220, AND 2517506-2018-00221 WERE FILED FOR THE SAME CUSTOMER INQUIRY. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY ELEVATED TPSA PATIENT RESULT WAS OBTAINED ON THE DIMENSION VISTA SYSTEM. THE CUSTOMER CONFIRMED THAT THERE HAVE BEEN NO ISSUES WITH QUALITY CONTROL (QC) AND ALL SURVEY RESULTS WERE GOOD. SIEMENS HEADQUARTERS SUPPORT CENTER EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER INCLUDING INFORMATION THE CUSTOMER PROVIDED ON RESULTS WITH THE SAME SAMPLE WHEN TREATED WITH A HETEROPHILE ANTIBODY BLOCKING TUBE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TPSA PATIENT RESULT IS UNKNOWN. HSC NOTED THAT THE RESULTS ARE CONSISTENT WITH A HETEROPHILIC ANTIBODY INTERFERENCE AS INDICATED IN THE DIMENSION VISTA TPSA INSTRUCTIONS FOR USE. THE DIMENSION VISTA? TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX? REAGENT CARTRIDGE INSTRUCTIONS STATES: PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE FROM ALL PATIENT SPECIMENS CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS INSTRUMENT IS REQUIRED.

D

Patient 1

A DISCORDANT, FALSELY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THIS RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED BY AN ALTERNATE NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TPSA RESULT.