FDA.reportPublic FDA data

MAUDE MDR 6411826

MDR report key
6411826
Report number
1219913-2017-00062
Event key
0
Event type
3
Date of event
2017-02-19
Date received
2017-03-16
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVIA CENTAUR XP VB12 ASSAYVB12 IMMUNOASSAY,SIEMENS HEALTHCARE DIAGNOSTICS, INC.CDDN/A1030997046513231N N
1331033ADVIA CENTAUR XP VB12 ASSAYVB12 IMMUNOASSAY,SIEMENS HEALTHCARE DIAGNOSTICS, INC.CDDN/A1030997046513231N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-160

Event Narratives#

N

Patient 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE CSE DID NOT OBSERVE ANY INSTRUMENT ISSUES. THE CAUSE FOR THE FALSELY ELEVATED OR IMPRECISE ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS WHEN COMPARING THE ADVIA CENTAUR XP SYSTEMS, OR ELEVATED RESULTS COMPARED TO AN ALTERNATE VB 12 TEST METHOD IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTIONS FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

D

Patient 1

FALSELY ELEVATED OR IMPRECISE ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS WERE OBSERVED WHEN COMPARING THE RESULTS FROM ONE ADVIA CENTAUR XP SYSTEM TO ANOTHER ADVIA CENTAUR XP SYSTEM, AND IN SOME CASES ELEVATED COMPARED TO AN ALTERNATE VB 12 TEST METHOD. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED VB12 RESULTS.

N

Patient 1

SIEMENS FILED THE INITIAL MDR 1219913-2017-00062 ON 03/16/2017 FOR FALSELY ELEVATED ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS. ON (B)(6) 2017 - ADDITIONAL INFORMATION: A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE. THE CSE DID NOT IDENTIFY ANY INSTRUMENT RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE ADVIA CENTAUR XP ELEVATED RESULTS. THE CSE CHANGED SAMPLE TUBES, CENTRIFUGE SPEEDS, AND PROACTIVELY PERFORMED PREVENTIVE MAINTENANCE (PM). THE CAUSE FOR THE ELEVATED ADVIA CENTAUR XP VB12 (VITAMIN B12) RESULTS IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.