Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ELECSYS TSH ASSAY; 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 ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Model Number TSH
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The sample was requested for investigation.
 
Event Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys ft4 iii (ft4 iii) on a cobas e 801 module compared to the siemens method.Based on the data provided, discrepant results for ft3 iii, tsh and anti-tshr were also identified.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results and to medwatch with patient identifier (b)(6) for information on the anti-tshr results.The results from the e801 module were reported outside of the laboratory.The e801 module serial number was (b)(4).
 
Manufacturer Narrative
No sample material was received for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELECSYS TSH ASSAY
Type of Device
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9538920
MDR Text Key219593969
Report Number1823260-2020-00013
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
PMA/PMN Number
ASKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTSH
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-