FDA.reportPublic FDA data

MAUDE MDR 7898155

MDR report key
7898155
Report number
1823260-2018-03233
Event key
0
Event type
3
Date of event
2018-08-31
Date received
2018-09-21
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
1TRIGB TRIGLYCERIDES/GLYCEROL BLANKEDLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDESROCHE DIAGNOSTICSCDTNA05976006190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-210

Event Narratives#

N

Patient 1

D

Patient 1

THE CUSTOMER COMPLAINED OF LOW DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR TRIGB TRIGLYCERIDES/GLYCEROL BLANKED (TRIGB) ON A COBAS 8000 C 702 MODULE. PATIENT 1 INITIAL TRIGB RESULT WAS 319 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. ON (B)(6) 2018 THE SAMPLE WAS REPEATED AND THE RESULT WAS 232 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH AUTO-DILUTION AND THE RESULT WAS 4121 MG/DL. ON (B)(6) 2018 PATIENT 2 (FEMALE, (B)(6)) INITIAL TRIGB RESULT WAS 558 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. ON (B)(6) 2018 THE SAMPLE WAS REPEATED AND THE RESULT WAS 514 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH AUTO-DILUTION AND THE RESULT WAS 3511 MG/DL. ON (B)(6) 2018 PATIENT 3 (FEMALE, (B)(6)) INITIAL TRIGB RESULT WAS 681 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. THE SAMPLE WAS REPEATED WITH AUTO-DILUTION AND THE RESULT WAS 3337 MG/DL. THE REPEAT RESULTS USING AUTO-DILUTION WERE BELIEVED TO BE CORRECT. NO ADVERSE EVENT OCCURRED. THE C702 MODULE SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND THE SYSTEM WAS OPERATING NORMALLY AND THERE WAS NO ISSUE WITH THE C702 MODULE. THE CUSTOMER HAS NOT HAD ANY FURTHER EVENTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.