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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Catalog Number 08429324160
Device Problems Low Test Results (2458); Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.
 
Event Description
The initial reporter received questionable tsh results on a cobas 6000 e601 module serial number, (b)(4). The initial result was 0. 028 iu/ml and the repeated result was 2. 33 iu/ml. The initial result was reported outside of the laboratory. The repeated result was believed to be correct.
 
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Brand NameTSH ELECSYS COBAS E 200 V2
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 Key10742457
MDR Text Key214803346
Report Number1823260-2020-02676
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue Number08429324160
Device Lot Number466153
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 Received10/01/2020
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 Invalid Data

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