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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
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ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Model Number TSH
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
The serial number for the cobas e 411 used at the investigation site was (b)(4).The tsh reagent lot used on this cobas e 411 was 402248 with an expiration date of 30-nov-2019.The ft4 iii reagent lot used on this cobas e 411 was 378826 with an expiration date of 31-aug-2019.The ft3 iii reagent lot used on this cobas e 411 was 396459 with an expiration date of 31-mar-2020.The investigation is ongoing.This event occurred in (b)(6).
 
Event Description
The initial reporter complained of questionable thyroid results for 4 patient samples on a cobas 8000 e 801 module.The patient samples were submitted for investigation where discrepant results were identified for 3 patient samples.There were discrepant tsh assay results identified for patient sample 1 between an e411 and the siemens centaur method used at the investigation site.There were discrepant elecsys ft4 iii assay results identified for patient sample 2 between the customer's e801 module, the cobas e 411 immunoassay analyzer used at the investigation site, and the siemens centaur method used at the investigation site.There were discrepant elecsys ft3 iii results identified for patient sample 3 between the customer's e801 module, the cobas e 411 immunoassay analyzer used at the investigation site, and the siemens centaur method used at the investigation site.It was asked but known if the questionable results from the customer site were reported outside of the laboratory.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4iii results and medwatch with patient identifier (b)(6) for information on the ft3 iii results.Refer to the attachment to the medwatch for all patient data.The customer's cobas e 801 serial number was not provided.
 
Manufacturer Narrative
Three samples were returned for investigation.The investigation reproduced the customer¿s roche results.An interfering factor in the samples was 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 TSH ASSAY
Type of Device
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9007521
MDR Text Key219205027
Report Number1823260-2019-03284
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
PMA/PMN Number
K961491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTSH
Device Catalogue Number07028091190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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