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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 Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). All tsh results from all types of analyzers were considerably above the normal reference range for the respective assays. Calibration and qc at the investigation site were acceptable. From the information provided, a general reagent issue can be excluded. Assays from different manufacturers can generate different results. This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used. The investigation did not identify a product problem. (b)(6).
 
Event Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys tsh (tsh) on a cobas e801 module compared to the accuraseed method. The date of event at the customer site is unknown. The date of event is an approximation. The sample was submitted for investigation where discrepant results were identified for tsh, elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) between the customer's e801 module, an e801 module used at the investigation site, the accuraseed method and the architect method. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results and medwatch with patient identifier (b)(6) for information on the ft3 iii results. Refer to attached data for the patient results. The customer's e801 module serial number was (b)(4). The e801 module used at the investigation site was (b)(4). The tsh reagent lot number used at the investigation site was 416233 with an expiration date of oct-2020.
 
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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
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 Key9658826
MDR Text Key199111229
Report Number1823260-2020-00258
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K961491
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 02/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
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
Type of Device Usage

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