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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 E801
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
The country of origin is (b)(6). A general reagent problem was ruled out because of the investigation. All values, generated with all types of analyzers, are considerably above the upper level of the normal reference ranges of the respective assays. Assays from different vendors can generate different values. This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used. The investigation did not identify a product problem. The cause of the event could not be determined.
 
Event Description
The initial reporter received questionable elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii results from the cobas 8000 e 801 module serial number (b)(4). This mdr will cover the elecsys tsh assay reagent. Refer to the mdr with patient identifier
=
(b)(6) for the elecsys ft4 iii assay reagent and refer to the mdr with patient identifier
=
(b)(6) for the elecsys ft3 iii assay reagent. The questionable results were reported outside the laboratory and an investigation was requested.
 
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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 Key9699018
MDR Text Key201373058
Report Number1823260-2020-00395
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 02/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE801
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 Received01/16/2020
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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