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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
Model Number T4
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2023
Event Type  malfunction  
Event Description
The initial reporter received questionable elecsys t3 and elecsys t4 assay results from two patient samples tested on the cobas e 801 module with unknown serial number.The reporter stated that the results they obtained from the module were significantly higher than those from an abbott system.The initial results were not reported outside of the laboratory.This medwatch is for the t4 assay.Please refer to medwatch with patient identifier: (b)(6) for the t3 assay.Please refer to the attachment in the medwatch for the table containing the questionable results.The reporter stated that the results from each method were not presenting the same clinical interpretation.
 
Manufacturer Narrative
The patient samples are not available for investigation.Qc data for t3 was acceptable.Based on the information provided, a general reagent issue can most likely be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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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 Key16631540
MDR Text Key312436961
Report Number1823260-2023-00999
Device Sequence Number1
Product Code CDX
UDI-Device Identifier07613336171677
UDI-Public07613336171677
Combination Product (y/n)N
Reporter Country CodeIN
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
Report Date 03/28/2023
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 Model NumberT4
Device Catalogue Number09007784190
Device Lot Number653184
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2023
Initial Date FDA Received03/28/2023
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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