FDA.reportPublic FDA data

MAUDE MDR 6741762

MDR report key
6741762
Report number
2432235-2017-00426
Event key
0
Event type
3
Date of event
2017-06-29
Date received
2017-07-25
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 AVE 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 1800ADVIA 1800SIEMENS HEALTHCARE DIAGNOSTICS INC.CHSADVIA 1800N N
1ADVIA 1800ADVIA 1800SIEMENS HEALTHCARE DIAGNOSTICS INC.JJEADVIA 1800N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-250

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE DISCORDANT CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT. THE QUALITY CONTROL (QC) WAS IN RANGE ON THE DAY OF EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE FOUND THE REACTION TRAY (RRV) OVERFLOWING FROM THE REACTION TRAY WASH UNIT (WUD) POSITION 2. THE CSE REPLACED THE REACTION TRAY WASH UNIT DRAIN VALVE 2 (CDEV2), AND CHECKED ASPIRATE AND OVERFLOW LINES FOR PLUGS. THE CSE CLEARED WUD PROBES, AND FOUND THE TUBING FOR THE WUD 2 ASPIRATE LOOSE AT THE WUD PROBE. THE CSE REPLACED TUBING, FOUND CONNECTOR FOR WUD 2 OVERFLOW LOOSE AT THE WUD PROBE, AND TIGHTENED. THE CSE STARTED WASH 3, AND OBSERVED NO OVERFLOW. THE CSE CLEANED THE LIQUID OFF OF THE CUVETTES, AND FOUND WATER IN THE REACTION TRAY (RRV) OIL. THE CSE CLEARED WATER FROM THE RRV OIL. THE CUSTOMER RAN AND VERIFIED QC, AND QC WAS IN RANGE. THE CSE OBSERVED NO SIGNS OF OVERFLOWING. THE CAUSE OF THE DISCORDANT CO2_C RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

D

Patient 1

A DISCORDANT, FALSELY HIGH CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME ADVIA INSTRUMENT, AND RECOVERED LOWER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY HIGH CO2_C RESULT.