FDA.reportPublic FDA data

MAUDE MDR 6854629

MDR report key
6854629
Report number
1823260-2017-01940
Event key
0
Event type
3
Date of event
2017-08-22
Date received
2017-09-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1TRIGL TRIGLYCERIDESTRIGLYCERIDES GPO WITHOUT FREE GLYCEROLROCHE DIAGNOSTICSCDTNA05171407190238467R Y

Patients#

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

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TRIGL TRIGLYCERIDES (TRIGL) ON A COBAS 8000 C 702 MODULE (C702). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 397 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND C702 ANALYZER, RESULTING AS 1130 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SECOND C702 ANALYZER WITH A DECREASED SAMPLE VOLUME, RESULTING AS 3986 MG/DL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. ACCORDING TO PRODUCT LABELING, EXTREMELY LIPEMIC SAMPLES CAN PRODUCE NORMAL RESULTS. THE CUSTOMER WAS NOT USING THE MOST CURRENT VERSION OF THE APPLICATION PARAMETERS. IN THE MOST CURRENT TEST APPLICATION VERSION, THE PROZONE CHECK LIMIT VALUE WAS REDUCED IN ORDER TO ALLOW FLAGGING OF INCORRECT LOW TRIGLYCERIDE RESULTS OF LIPEMIC PATIENT SAMPLES ON THE C702 ANALYZER. THE CUSTOMER HAS UPDATED THE APPLICATION PARAMETERS TO THE MOST CURRENT VERSION AND HAVE NOT EXPERIENCED ANY FURTHER ISSUES.