FDA.reportPublic FDA data

MAUDE MDR 5263863

MDR report key
5263863
Report number
1823260-2015-04675
Event key
0
Event type
3
Date of event
2015-08-25
Date received
2015-12-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
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
1T4RADIOIMMUNOASSAY, TOTAL THYROXINEROCHE DIAGNOSTICSCDXNAASKU182845R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-030

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER QUESTIONED RESULTS FROM 2 SAMPLES FROM THE SAME PATIENT TESTED FOR THYROTROPIN (TSH), FREE THYROXINE (FT4) AND FT3 -FREE TRIIODOTHYRONINE (FT3 III). THE CUSTOMER PROVIDED THE PATIENT SAMPLES FOR INVESTIGATION. OF THE SAMPLES PROVIDED, ERRONEOUS FT3 III RESULTS WERE IDENTIFIED FOR 1 SAMPLE BETWEEN THE CUSTOMER'S E602 ANALYZER, A CENTAUR ANALYZER, AND A MODULAR E ANALYZER USED AT THE INVESTIGATION SITE. BASED ON THE DATA PROVIDED, ERRONEOUS T4 RESULTS WERE IDENTIFIED FROM THE SAME SAMPLE BETWEEN THE MODULAR E ANALYZER USED AT THE INVESTIGATION SITE AND THE CENTAUR. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III ERRONEOUS RESULTS. SEE THE ATTACHMENT TO THE MEDWATCH FOR PATIENT RESULTS. NO ADVERSE EVENT WAS REPORTED. THE MODULAR E ANALYZER SERIAL NUMBER WAS (B)(4).

N

Patient 1

THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE REPRODUCED. THE T4 RESULTS WERE WITHIN THE REFERENCE RANGE. INTERFERENCE TESTING WAS PERFORMED. NO INTERFERENCES WERE IDENTIFIED. THE VALUES OF A GIVEN PARAMETER GENERATED BY ASSAYS FROM DIFFERENT SUPPLIERS MAY BE DIFFERENT DUE TO THE OVERALL SETUP OF THE ASSAY, THE ANTIBODIES USED AND DIFFERENCES IN REFERENCE MATERIALS/METHODS AND THE STANDARDIZATION METHOD USED. FURTHER CLARIFICATION OF THE DIFFERENCES BETWEEN THE ROCHE AND SIEMENS CENTAUR ANALYZERS IS NOT POSSIBLE WITH THE CURRENT METHODS AVAILABLE.