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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 05/03/2023
Event Type  malfunction  
Manufacturer Narrative
The analyzer serial number is (b)(6).An interfering substance is suspected in the patient sample.The patient sample was requested for investigation.The investigation is ongoing.
 
Event Description
There was an allegation of questionable elecsys t4 assay results for 1 patient sample on a cobas e 801 analytical unit compared to a beckman analyzer.Refer to the attachment to the medwatch for all patient data.Clarification on if the results from (b)(6) 2023 were from a new sample was requested but not provided.The results were reported outside of the laboratory.
 
Manufacturer Narrative
The beckman analyzer results were produced on (b)(6) 2023.The results from (b)(6) 2023 were obtained from the same sample.The qc recovery data provided was acceptable.A general product problem could be excluded.The investigation found that the patient sample contains an interfering factor to the streptavidin component of the reagent.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.".
 
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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 Key17136179
MDR Text Key317325728
Report Number1823260-2023-01975
Device Sequence Number1
Product Code CDX
UDI-Device Identifier07613336171677
UDI-Public07613336171677
Combination Product (y/n)N
Reporter Country CodeCH
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 07/25/2023
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 Number62733100
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/17/2023
Initial Date FDA Received06/15/2023
Supplement Dates Manufacturer Received07/12/2023
Supplement Dates FDA Received07/25/2023
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
Treatment
ADENINE ARABINOSIDE MONOPHOSPHATE; ETAMSYLATE; GAMMA GLOBULIN
Patient Age2 YR
Patient SexMale
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