FDA.reportPublic FDA data

MAUDE MDR 2961865

MDR report key
2961865
Report number
2247117-2013-00016
Event key
0
Event type
3
Date of event
2013-01-23
Date received
2013-02-14
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
MR. MICHAEL METZ
Address
511 BENEDICT AVENUE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMMULITE 2000IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICSDGCIMMULITE 200030002N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-140

Event Narratives#

D

Patient 1

DISCORDANT, NON-LINEAR DILUTION RESULTS FOR CA-125 ANTIGEN WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE CUSTOMER WAS PERFORMING A 1:10 AND A 1:100 DILUTION ON THE PATIENT SAMPLES, AND THE RESULTS WERE NOT LINEAR RELATIVE TO THE NEAT RESULTS. DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NON-LINEAR RESULTS.

N

Patient 1

THE CAUSE OF THE NON-LINEAR DILUTION RESULTS ON PATIENT SAMPLES FOR CA-125 IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

N

Patient 1

THE INITIAL MDR 2247117-2013-00016 WAS FILED ON (B)(4) 2013 ADDITIONAL INFORMATION ((B)(4) 2013): A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE SAMPLE DUAL RESOLUTION DILUTOR (DRD). THE FSE RAN 1:10 AND 1:100 DILUTIONS IN REPLICATES OF TEN AND THEN RAN A SYSTEM QC. ALL THE DATA WERE WITHIN RANGE. THERE WERE NO FURTHER ISSUES WITH CA 125 AND ALL THE RESULTS AFTER THE FSE VISIT WERE ACCEPTABLE TO THE CUSTOMER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.