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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

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ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE Back to Search Results
Catalog Number 12017709122
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The event occurred in: (b)(6).
 
Event Description
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.
 
Manufacturer Narrative
Lot no updated.
 
Manufacturer Narrative
A patient sample was received for further investigation.The tsh, ft4, ft3, t4, and t3 values generated at the customer site were confirmed.Upon further analysis an interfering factor was detected.This most likely caused the falsely elevated values of the ft4ii, ft3iii, and t4 and an increase value of t3.This interference is covered in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The incidence rate of the identified interfering factor is monitored on a quarterly basis.
 
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Brand Name
ELECSYS T4 ASSAY
Type of Device
RADIOIMMUNOASSAY, TOTAL THYROXINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key7139331
MDR Text Key95824120
Report Number1823260-2017-03102
Device Sequence Number1
Product Code CDX
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
K961490
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number12017709122
Device Lot Number194281
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2017
Initial Date FDA Received12/21/2017
Supplement Dates Manufacturer Received12/14/2017
12/14/2017
Supplement Dates FDA Received01/05/2018
01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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