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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE Back to Search Results
Catalog Number 07027885190
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2023
Event Type  malfunction  
Manufacturer Narrative
The sample was requested for a sample interference investigation.The investigation is ongoing.
 
Event Description
There was an allegation of questionable elecsys t4 assay results for 1 patient sample on a cobas 6000 e601 module and a cobas e 801 analytical unit.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6).For information on the ft3 iii results.The t4 result on the e601 analyzer was >320 nmol/l.The sample was tested on another laboratory's e801 analyzer and the result was 186 nmol/l.No questionable results were reported outside of the laboratory.The e601 analyzer serial number (b)(4).The other laboratory's e801 analyzer serial number was requested but not provided.
 
Manufacturer Narrative
Two patient samples were provided for investigation.An interfering substance to the ruthenium component of the reagent was detected.Per product labeling, "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." the investigation did not identify a product problem.
 
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Brand Name
ELECSYS T4
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
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key16658616
MDR Text Key313196403
Report Number1823260-2023-01050
Device Sequence Number1
Product Code CDX
UDI-Device Identifier04015630939800
UDI-Public04015630939800
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K961490
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/15/2023
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 Number07027885190
Device Lot Number65318702
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2023
Initial Date FDA Received03/31/2023
Supplement Dates Manufacturer Received04/19/2023
Supplement Dates FDA Received05/15/2023
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
Patient Sequence Number1
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