FDA.reportPublic FDA data

MAUDE MDR 7300026

MDR report key
7300026
Report number
1823260-2018-00587
Event key
0
Event type
3
Date of event
2018-02-08
Date received
2018-02-27
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
1ELECSYS T4 ASSAYRADIOIMMUNOASSAY, TOTAL THYROXINEROCHE DIAGNOSTICSCDXNAASKUASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-270

Event Narratives#

N

Patient 1

(B)(6). (B)(4).

D

Patient 1

THE CUSTOMER COMPLAINED OF HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT4 II ASSAY (FT4 II) AND ELECSYS FT3 III (FT3 III) ON A COBAS 6000 E 601 MODULE. THE INITIAL FT3 III AND FT4 II RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN COMPLAINED THAT THE RESULTS DID NOT CORRESPOND TO THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS SENT FOR TESTING BY THE ABBOTT METHOD ALONG WITH REPEAT TESTING WITH AN EDTA PLASMA SAMPLE ON THE CUSTOMER'S E601 MODULE AND REPEAT TESTING ON ANOTHER HOSPITALS E601 MODULE. BASED ON THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR FT4 II, FT3 III, ELECSYS T3 (T3) AND ELECSYS T4 ASSAY (T4). REFER TO MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR THE ASSAYS INVOLVED: (B)(6). THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER'S E601 SERIAL NUMBER WAS (B)(4). THE E601 SERIAL NUMBER USED AT THE EXTERNAL LABORATORY WAS NOT PROVIDED.