FDA.reportPublic FDA data

MAUDE MDR 6304062

MDR report key
6304062
Report number
2432235-2017-00100
Event key
0
Event type
3
Date of event
2017-01-10
Date received
2017-02-06
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CASSANDRA KOCSIS
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
0ADVIA 2400ADVIA 2400SIEMENS HEALTHCARE DIAGNOSTICS INC.DCNADVIA 2400N N
1ADVIA 2400ADVIA 2400SIEMENS HEALTHCARE DIAGNOSTICS INC.JJEADVIA 2400N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-060

Event Narratives#

N

Patient 1

THE DISTRIBUTOR CONTACTED A SIEMENS CUSTOMER CARE CENTER SPECIALIST AND STATED THAT THE OPERATORS HAD OBTAINED ABNORMAL REACTION CURVES WHILE RUNNING THE PATIENT SAMPLES. REACTION CURVES SUGGESTED THAT THE REAGENT WAS NOT ADDED. SOME ABNORMAL REACTION CURVES ALSO HAD VARIANCE FLAGS, WHICH MEAN THAT PHOTOMETRIC TESTS ASSAY DATA WAS IMPRECISE. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE REACTION CURVE DATA AND DETERMINED THAT THERE WAS NO SYSTEMIC INSTRUMENT OR REAGENT ISSUE. THE INFORMATION PROVIDED WAS CONSISTENT WITH A SAMPLE OR REAGENT DELIVERY ISSUE. THE HSC SPECIALIST RECOMMENDED THAT PRIOR TO PLACEMENT OF THE REAGENT OR SAMPLES ON THE SYSTEM, THE MATERIALS SHOULD BE CHECKED FOR FOAM OR BUBBLES, WHICH CAN CAUSE POOR ASPIRATION AND IMPACT RESULTS. POOR MIXING COULD ALSO IMPACT RESULTS AND MAY PRODUCE SIMILAR FLAGS. THE CAUSE OF THE DISCORDANT WRCRP RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

THE CUSTOMER OF AN ADVIA 2400 INSTRUMENT OBTAINED DISCORDANT WIDE RANGE C-REACTIVE PROTEIN (WRCRP) RESULTS ON MULTIPLE PATIENT SAMPLES. THE INITIAL RESULTS HAD ABNORMAL REACTION CURVES. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND CORRECT REACTION CURVES WERE OBTAINED FOR THE REPEAT RUNS. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT WRCRP RESULTS.