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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 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
The serial number for the cobas e 801 used at the investigation site was (b)(4). The ft3 iii reagent lot used on this cobas e 801 was 348359 with an expiration date of 31-oct-2019. The serial number for the cobas e 602 used at the investigation site was (b)(4). The tsh reagent lot used on this cobas e 602 was 394647 with an expiration date of 31-oct-2019. The serial number for the cobas e 411 used at the investigation site was (b)(4). The ft3 iii reagent lot used on this cobas e 411 was 347456 with an expiration date of 30-sep-2019. The investigation is ongoing. The event occurred in (b)(6).
 
Event Description
The initial reporter complained of questionable thyroid results for 1 patient sample tested for ft3 iii assay on a cobas 8000 e 801 module. The patient sample was submitted for investigation. There were discrepant results identified for elecsys ft3 iii between the customer's e 801 module, an e 801 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site, and the siemens centaur method used at the investigation site. There were discrepant results identified for elecsys tsh assay between the cobas 8000 e 602 module and the siemens centaur method used at the investigation site. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results. It was asked but not known if the questionable results from the customer site were reported outside of the laboratory. Refer to the attachment to the medwatch for all patient data. The e 801 module serial number was (b)(4).
 
Manufacturer Narrative
A sample was returned for investigation. The customer¿s results were confirmed in the investigation. No interfering factor was found in the sample. The differences of the tsh values, generated with the different types of analyzers, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.
 
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Brand NameELECSYS TSH ASSAY
Type of DeviceRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8916355
MDR Text Key176642787
Report Number1823260-2019-03067
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 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number07028091190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No

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