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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 ASKU
Device Problems High Test Results (2457); Chemical Problem (2893)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The investigation is ongoing.
 
Event Description
There was an allegation of questionable elecsys t3, elecsys t4 assay, and elecsys tsh assay results for 6 patient samples on a cobas e 801 analytical unit compared to tree competitor analyzers.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6) for information on the t3 results and medwatch with a1 patient identifier (b)(6) for information on the tsh results.Refer to the attachment to the medwatch for all patient data.The units of measurement for the tsh results and for the competitor analyzer results were not provided.The reference ranges for all assays were not provided.
 
Manufacturer Narrative
Section d4 reagent lot number has been updated.The customer's t4 reference range is 5.1-14.1 ug/dl.The customer stated that their qc recovery data was acceptable.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.
 
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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
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key18365980
MDR Text Key331333758
Report Number1823260-2023-04138
Device Sequence Number1
Product Code CDX
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
ASKU
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 02/29/2024
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 NumberASKU
Device Lot Number711668
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2023
Initial Date FDA Received12/20/2023
Supplement Dates Manufacturer Received02/13/2024
Supplement Dates FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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