• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 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 12/12/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested with the following assays on two cobas 8000 e 602 module analyzers: the elecsys tsh assay, the elecsys tsh assay ver. 2, elecsys ft3 iii, the elecsys ft4 iii assay, the elecsys anti-tshr immunoassay, and the elecsys anti-tshr ver. 2 immunoassay. This medwatch will cover the tsh v2 assay. Refer to the medwatches with the following patient identifiers for information related to all other assays: (b)(6). Refer to the attachment for all patient sample data. The sample was collected on (b)(6) 2020 and run five times on the customer's e 602 analyzer on (b)(6) 2020. The sample was also diluted x2 and repeated for tsh and tsh v2 on the customer's e 602 analyzer. The sample was repeated on an abbott architect analyzer. The sample was also provided for investigation, where it was tested on a second e 602 analyzer on (b)(6) 2020. The serial number of the customer's e 602 analyzer is (b)(4). The tsh v2 reagent lot number used on this analyzer was 484229. The reagent expiration date is unknown. The serial number of the e 602 analyzer used for investigation is (b)(4). Tsh v2 reagent lot number 484229, with an expiration date of may 2021 was used on this analyzer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11125681
MDR Text Key268261450
Report Number1823260-2021-00054
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 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number08429324190
Device Lot Number484229
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 Received12/12/2020
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

-
-