FDA.reportPublic FDA data

MAUDE MDR 4618148

MDR report key
4618148
Report number
2432235-2015-00134
Event key
0
Event type
3
Date of event
2015-02-26
Date received
2015-03-19
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
CASSANDRA KOCSIS
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
1ADVIA CENTAURIMMUNOASSAY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.MOIADVIA CENTAUR078-A001-08N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-190

Event Narratives#

D

Patient 1

DISCORDANT RESULTS WERE OBTAINED ON PATIENT SAMPLES TESTED FOR MULTIPLE METHODS ON AN ADVIA CENTAUR INSTRUMENT. IT IS UNKNOWN IF DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF REPEAT TESTING WAS PERFORMED AND IF CORRECTED REPORTS WERE SENT OUT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

N

Patient 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. PRIOR TO CSE ARRIVAL, THE CUSTOMER TRIED TO PERFORM THE MONTHLY MAINTENANCE PROCEDURE, WHICH FAILED. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE FOUND CLUMPY REAGENTS AND A CENTAUR WATER BOTTLE NEXT TO THE SYSTEM THAT WAS FILLED WITH CONTAMINATED FLUID. THE CSE ASKED THE CUSTOMER NOT TO USE THE SYSTEM WATER BOTTLES FOR WASTE OR ANY OTHER FLUIDS EXCEPT DEIONIZED WATER OR CLEANING SOLUTION AND TO USE THEIR REAGENT GRADE DEIONIZED WATER CONTAINERS TO FILL THE SYSTEM WATER BOTTLE UNTIL THE QUALITY OF THEIR DEIONIZED TAP WATER COULD BE VERIFIED. THE CSE ALSO DISCOVERED THAT THE REFRIGERATOR THAT IS BEING USED TO STORE THE CENTAUR REAGENTS IS IN A HALLWAY NEXT TO A COLD GARAGE, AND THE REFRIGERATOR'S TEMPERATURE IS NOT BEING MONITORED FOR THE DAILY MINIMUM AND MAXIMUM TEMPERATURES. THE CSE DISCUSSED THE ISSUE WITH THE CUSTOMER AND TWO DIGITAL THERMOMETERS WERE INSTALLED IN THE REFRIGERATOR. THE CSE PERFORMED THE MONTHLY CLEANING PROCEDURE, WITHOUT ISSUES. THE CUSTOMER RAN QUALITY CONTROLS. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.