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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter complained of questionable results for 46 patient samples tested for ft4 iii assay on a cobas 8000 e 801 module compared to the beckman dxl. Of the data provided, there were 7 patient samples with discrepant ft4 iii and elecsys tsh assay results, 21 patient samples with discrepant ft4 iii results, and 9 patient samples with discrepant tsh results. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results. The e 801 module serial number was (b)(4).
 
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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 Key8887465
MDR Text Key154169483
Report Number1823260-2019-02961
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeEI
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 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue NumberASKU
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 Received07/18/2019
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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