FDA.reportPublic FDA data

MAUDE MDR 5529344

MDR report key
5529344
Report number
1823260-2016-00351
Event key
0
Event type
3
Date of event
2016-03-08
Date received
2016-03-28
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 8000 E602 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJMGNA05990378001NAR Y
1COBAS 8000 E602 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJENA05990378001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-280

Event Narratives#

N

Patient 1

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

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR FERRITIN ON AN E602 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 1.19 UG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIAN. THE PHYSICIAN DID NOT TRUST THE RESULT AND ASKED FOR THE SAMPLE TO BE REPEATED. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER, RESULTING AS 20.17 UG/L. THE SAMPLE WAS ALSO REPEATED ON AN E170 ANALYZER, RESULTING AS 18.46 UG/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FERRITIN REAGENT LOT NUMBER WAS 121669. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THAT REAGENT CUPS ON THE ANALYZER WERE DIRTY. HE CLEANED THE CUPS AND PERFORMED A MEASURING CELL PREPARATION. HE CHECKED SAMPLE ADJUSTMENT AND THIS WAS OK. HE DID NOT DETECT ANY OTHER ISSUES WITH THE SYSTEM. HE RAN PERFORMANCE TESTING. HE STATED THAT THE OVERALL CLEANLINESS OF THE LABORATORY WAS GOOD.

N

Patient 1

IT WAS STATED THAT THE PERFORMANCE TESTING RUN ON THE ANALYZER WAS SUCCESSFUL. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A GENERAL REAGENT OR INSTRUMENT ISSUE COULD NOT BE SEEN.