FDA.reportPublic FDA data

MAUDE MDR 2542017

MDR report key
2542017
Report number
2050012-2012-00994
Event key
0
Event type
3
Date of event
2012-03-22
Date received
2012-04-19
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
MS. DUNG NGUYEN
Address
250 S. KRAEMER BLVD. BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNCHRON CX3 DELTAANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USEBECKMAN COULTER, INC.JJFNA467501Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-190

Event Narratives#

D

Patient 1

CUSTOMER CALLED TO REPORT THAT THE SYNCHRON CX3 DELTA GENERATED FALSELY HIGH CARBON DIOXIDE (CO2) RESULTS ON THREE PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, WHEN ANION GAPS FLAGGED THE SAMPLES, FIVE OF THE SAMPLES WERE RERUN AND THREE OF THE REPORTS WERE AMENDED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT CERTAIN HARDWARE PARTS REQUIRED REPLACEMENT AND MAINTENANCE. THE FSE REPLACED THE CO2 MEASURING ELECTRODE AND THE ELECTROLYTE INJECTION CUP (EIC) DRAIN VALVE. THE FSE ALSO CLEANED THE FLOWCELL. THE FSE THEN VERIFIED PROPER INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT.

N

Patient 1

(B)(4).