• 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 FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

  • 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 FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE Back to Search Results
Model Number FT3 G3
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module compared to the abbott architect method.The results from the e602 module were reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where discrepant results were also identified for ft4 iii and ft3 iii from an e602 module used at the investigation site compared to the abbott method.This medwatch will cover ft3 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results.The customer¿s e602 module serial number was not provided.The e602 module serial number used at the investigation site was (b)(4).The ft3 iii reagent lot number used at the investigation site was 446738 with an expiration date of dec-2020.
 
Manufacturer Narrative
The sample was investigated further.The ft4 iii and ft3 iii results (both at the customer site and during the preliminary investigation) were confirmed.The investigation confirmed, the presence of an interfering factor against the chemical ruthenium label structure of the assay.This specific interference is addressed in product labeling: 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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation did not identify a product problem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELECSYS FT3 III
Type of Device
RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10837050
MDR Text Key216159549
Report Number1823260-2020-02878
Device Sequence Number1
Product Code CDP
Combination Product (y/n)N
PMA/PMN Number
K963127
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 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Model NumberFT3 G3
Device Catalogue Number06437206190
Device Lot Number446738
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/13/2020
Supplement Dates Manufacturer Received10/21/2020
Supplement Dates FDA Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-