FDA.reportPublic FDA data

MAUDE MDR 5815040

MDR report key
5815040
Report number
1823260-2016-01034
Event key
0
Event type
3
Date of event
2016-06-29
Date received
2016-07-22
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
1CORTISOLENZYME IMMUNOASSAY, CORTISOL, SALIVARYROCHE DIAGNOSTICSNHGNAASKU189893R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-220

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4), AND CORTISOL ON AN E601 ANALYZER. THE PATIENT'S FT4 VALUE WAS SAID TO BE IMPLAUSIBLE AND WAS NOT FITTING THE PATIENT'S CLINICAL HISTORY. THE PATIENT HAD NO CLINICAL SYMPTOMS OF HYPERTHYREOSIS. THE PATIENT'S CORTISOL RESULT WAS SAID TO BE IMPLAUSIBLE. THERE WERE NO ERROR MESSAGES ON THE ANALYZER. IT WAS STATED THAT THE PATIENT SAMPLE BEHAVED STRANGELY WITH ALMOST ALL APPLIED ELECSYS ASSAYS. THIS MEDWATCH WILL COVER THE CORTISOL ASSAY. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY AND THE MEDWATCH WITH (B)(6) FOR INFORMATION RELATED TO FT4. THE PATIENT SAMPLE INITIALLY RESULTED AS 16.54 PMOL/L FOR FT3, > 100 PMOL/L FOR FT4, AND 1610 NMOL/L FOR CORTISOL. THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR DID NOT TRUST THE INITIAL VALUES, SO HE REQUESTED REPEAT ANALYSIS OF THE SAMPLE WITH ASSAYS FROM A DIFFERENT MANUFACTURER. THE SAMPLE WAS REPEATED ON A SIEMENS VISTA ANALYZER, RESULTING AS 7.56 PMOL/L FOR FT3, > 100 PMOL/L FOR FT4, AND 1441 NMOL/L FOR CORTISOL. THE CUSTOMER ALSO STATED THAT THE FT4 VALUE WAS UNCHANGED AFTER BLOCKING THE "HETEROPHILE AK". THE PATIENT WAS NOT ADVERSELY AFFECTED. THE E601 ANALYZER SERIAL NUMBER WAS (B)(4). THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. DURING INVESTIGATION OF THE SAMPLE, THE FT3, FT4, AND CORTISOL VALUES OBTAINED BY THE CUSTOMER COULD BE CONFIRMED. FURTHER INVESTIGATIONS OF THE SAMPLE DID NOT DETECT ANY INTERFERING FACTORS WITHIN THE SAMPLE. FOR THE DIFFERENCES SEEN IN THE FT3 RESULTS, DIFFERENT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS IS RELATED TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, THE DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND THE STANDARDIZATION METHODOLOGY USED. A GENERAL REAGENT ISSUE AT CUSTOMER SITE MOST LIKELY CAN BE EXCLUDED.