FDA.reportPublic FDA data

MAUDE MDR 5275217

MDR report key
5275217
Report number
2432235-2015-00573
Event key
0
Event type
3
Date of event
2015-11-06
Date received
2015-12-08
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
MARGARITA KARAN
Address
511 BENEDICT AVENUE TARRYTOWN 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0ADVIA CENTAUR XPIMMUNOASSAY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.MOIADVIA CENTAUR XPN N
1ADVIA CENTAUR XPIMMUNOASSAY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.JJEADVIA CENTAUR XPN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-080

Event Narratives#

N

Patient 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE PHOTOMULTIPLIER ASSEMBLY, TWO WAY VALVE, 2ML DILUTER ASSEMBLY, CAPACITANCE SENSOR ASSEMBLY AND TUBING. PRECISION WAS RUN, RESULTING IN FLIERS. THE CSE FOUND THE POWER CONNECTION TO ASPIRATE PROBE 1 WAS CORRODED, AND REPAIRED THE CONNECTION. THE CSE REPLACED THE SAMPLE SYRINGE, WASH MANIFOLD, 5ML DILUTER, AND VALVES 1 AND 4. THE CSE CHECKED THE ACID AND BASE, AND DISPENSE AND ASPIRATION OF THE WASH MANIFOLD. THE CSE ADJUSTED REAGENT PROBE 1 AT THE CUVETTE BOTTOM. PATIENT SAMPLE PRECISION WAS THEN ACCEPTABLE. THE CUSTOMER RAN QUALITY CONTROLS WHICH FAILED FOR LEVELS 2 AND 3. THE CSE REPLACED THE SAMPLE AND ANCILLARY PROBE TUBING, DILUTERS AND VALVES, AND SAMPLE PLUNGER AND NOZZLE. THE CSE DECONTAMINATED THE ACID AND BASE, AND REPLACED THE ANCILLARY BUBBLE DETECTOR. PRECISION WAS RUN AND COEFFICIENTS OF VARIATIONS WERE OUT OF RANGE. THE CSE DISCOVERED REAGENT PROBE 2 HAD LEAKED ONTO THE REAGENT PROBE 2 SENSOR BOARD. THE CSE REPLACED BOARD AND ARM ASSEMBLY, AND CALIBRATED TO THE RING AND WASH STATIONS. THE CSE REPLACED WASTE PROBE VALVE 28, FLUIDICS MANIFOLD VALVES AND TUBING, PHOTOMULTIPLIER, BASE PUMP, AND WASH MANIFOLD TUBING. MULTIPLE ASSAYS WERE CALIBRATED AND PRECISION WERE RUN, RESULTING WITHIN RANGE. QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT CA 27.29 RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

DISCORDANT CANCER ANTIGEN 27.29 (CA 27.29) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED TWICE, FIVE DAYS LATER, ON THE SAME INSTRUMENT, RESULTING HIGHER FOR SOME PATIENT AND LOWER ON OTHERS. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 27.29 RESULTS.