FDA.reportPublic FDA data

MAUDE MDR 6854831

MDR report key
6854831
Report number
1823260-2017-01948
Event key
0
Event type
3
Date of event
2017-08-21
Date received
2017-09-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ISE INDIRECT NA, K, CI FOR GEN.2REFERENCE ELECTRODEROCHE DIAGNOSTICSCGZCOBAS 8000 ISE03149501001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-110

Event Narratives#

N

Patient 1

UNIQUE IDENTIFIER (UDI)# (B)(4).

D

Patient 1

THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR ISE INDIRECT NA AND CI FOR GEN.2 FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED ONLY THE RESULT FOR CHLORIDE IS A REPORTABLE MALFUNCTION. THE INITIAL CHLORIDE RESULT WAS 71 MMOL/L WITH A REPEAT RESULT OF 106 MMOL/L. THE REPEAT TESTING WAS PERFORMED ON THE OTHER ION SELECTIVE ELECTRODE UNIT ON THE SAME COBAS 8000 COBAS ISE MODULE (DOUBLE) SYSTEM. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE INITIAL CHLORIDE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER AND EXPIRATION DATE FOR THE CHLORIDE ELECTRODE WAS REQUESTED BUT NOT PROVIDED. THE SAMPLE WAS PROCESSED BY A MODULAR PRE-ANALYTICS SYSTEM. THE FIELD ENGINEERING SPECIALIST FOUND BUILDUP AROUND THE MIXING VESSEL. HE CLEANED THE BUILDUP THAT HE FOUND ALONG THE MIXING VESSEL, ALONG WITH THE CLEANING AND CHECKING OF OTHER COMPONENTS. HE RAN PRECISION CHECKS WHICH WERE ACCEPTABLE. THE CUSTOMER RAN CALIBRATION AND QC WHICH ALL PASSED.