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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 High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
Sample from the patient was submitted for investigation. An interfering factor to ruthenium was identified in the sample. This interference was documented in product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design. No product problem could be found.
 
Manufacturer Narrative
The investigation is ongoing. This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable elecsys tsh assay results for one patient from cobas e 801 module serial number (b)(4). Sample from the patent was submitted for initial investigation and was tested on centaur, cobas e801, cobas e602, and cobas e411 analyzers. Refer to the attachment to the medwatch for all patient data. The customer reported out the results to a physician.
 
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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 Key9810612
MDR Text Key189570570
Report Number1823260-2020-00691
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,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2020
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 Received02/20/2020
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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