FDA.reportPublic FDA data

MAUDE MDR 5413062

MDR report key
5413062
Report number
1823260-2016-00110
Event key
0
Event type
3
Date of event
2016-01-13
Date received
2016-02-05
Adverse event
0
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
0COBAS 6000 E601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJMGE60104745922001NAR Y
1COBAS 6000 E601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEE60104745922001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-050

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). (B)(4).

D

Patient 1

THE CUSTOMER QUESTIONED HIGH RESULTS FOR 2 ONCOLOGY PATIENTS TESTED FOR FERRITIN. THE CUSTOMER HAD SWITCHED FROM THE ILAB 650 TURBIDIMETRIC METHOD TO THE E601 ANALYZER USING THE ELECTROCHEMILUMINESCENCE METHOD IN (B)(6) 2015 AND NOTICED A DIFFERENCE IN THE RESULTS FOR THESE 2 PATIENTS IN (B)(6) 2016. BASED ON THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT WERE ERRONEOUS AND REPORTED OUTSIDE OF THE LABORATORY WITH A NOTE THAT THE METHOD HAD CHANGED. THE INITIAL FERRITIN RESULT FROM THE E601 ANALYZER WAS >2000 NG/ML WITH A DATA FLAG. AFTER A MANUAL DILUTION OF 1:50 THE REPEAT RESULT WAS 32.77 NG/ML. THE CALCULATED RESULT WAS 1638 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. SINCE THE CUSTOMER IS QUESTIONING THE FERRITIN RESULTS FROM THE E601 ANALYZER, THEY ARE TESTING SAMPLES USING THE TURBIDIMETRIC METHOD ON A C501 ANALYZER. THE INITIAL SAMPLE WAS REPEATED ON A DIFFERENT DAY ON THE E601 ANALYZER AND THE RESULT WAS 4030 NG/ML. THIS SAMPLE WAS ALSO REPEATED ON THE C501 ANALYZER AND THE RESULT WAS 3569 NG/ML. THE CUSTOMER THINKS THE RESULTS FROM THE C501 ANALYZER ARE CORRECT AND NOW BELIEVES THE RESULTS FROM THE E601 ANALYZER SINCE THEY ARE COMPARABLE TO THE C501. THE LAST RESULT FROM A DIFFERENT SAMPLE ON THE ILAB 650 WAS 962 NG/ML. NO ADVERSE EVENT OCCURRED. THE FERRITIN REAGENT LOT NUMBER WAS 187143. THE EXPIRATION DATE WAS NOT PROVIDED.

N

Patient 1

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.A GENERAL FERRITIN REAGENT ISSUE CAN BE EXCLUDED SINCE QUALITY CONTROLS WERE ACCEPTABLE.