ELECSYS T4 ASSAY 12017709122

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-21 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.

Event Text Entries

[95824120] (b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[95824121] The customer received questionable thyroid results for 2 patient samples. Of the data provided, the elecsys t4 assay results that are a reportable malfunction apply to only 1 patient sample that was tested on a cobas 6000 e 601 module (serial number not provided) compared to the t4 results from a siemens-immulite 2000xpi, abbott-architect, and a beckman coulter. Please refer to the attachment for patient data. The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results, medwatch with patient identifier(b)(6) for information on the t3 erroneous results, and medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous result. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-03102
MDR Report Key7139331
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-12-21
Date of Report2018-01-24
Date of Event2017-12-06
Date Mfgr Received2017-12-14
Date Added to Maude2017-12-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameELECSYS T4 ASSAY
Generic NameRADIOIMMUNOASSAY, TOTAL THYROXINE
Product CodeCDX
Date Received2017-12-21
Model NumberNA
Catalog Number12017709122
Lot Number194281
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-21

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