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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

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ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE Back to Search Results
Model Number FT4 G3
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
Based on the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.Medwatch field udi number = (b)(4).This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received discrepant thyroid test results for two patient samples tested on two cobas 8000 e 801 modules, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.Results from the following assays were affected: the elecsys tsh assay, the elecsys tsh assay ver.2, and the elecsys ft4 iii assay.The values measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh, and refer to the medwatch with patient identifier (b)(6) for information related to the tsh ver.2 assay.Refer to the attachment for all patient data.The values highlighted in yellow were questioned.The samples were initially tested on the customer's e 801 analyzer on (b)(6)2021.The samples were repeated on a siemens centaur analyzer.The samples were also provided for investigation, where they were tested on the second e 801 analyzer and an e411 analyzer on (b)(6) 2021 and on an e 602 analyzer on (b)(6) 2021.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 483198, with an expiration date of 30-jun-2021 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of 31-may-2021 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of 31-may-2021 was used on this analyzer.
 
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Brand Name
ELECSYS FT4 III ASSAY
Type of Device
RADIOIMMUNOASSAY, FREE 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 Key11605560
MDR Text Key243545210
Report Number1823260-2021-00985
Device Sequence Number1
Product Code CEC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2021
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 NumberFT4 G3
Device Catalogue Number07976887190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received04/01/2021
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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