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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE
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ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE Back to Search Results
Catalog Number 07027397190
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
The customer questioned results from 1 patient sample tested for elecsys ft4 ii (ft4 ii), elecsys ft3 iii (ft3 iii) and elecsys tsh (tsh) on a cobas e 801 module.The patient sample was submitted for investigation where discrepant results were identified for ft4 ii, ft3 iii and tsh between the customer's e801 module, an e801 module used at the investigation site, a cobas 6000 e 601 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site and the centaur method.It is not known if any incorrect results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the ft3 iii results and medwatch with (b)(6) for information on the tsh results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The e601 module serial (b)(4).The e411 analyzer serial (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used with the e601 module was 288197 with an expiration date of 31-dec-2018.The ft4 ii reagent lot number used with the e411 analyzer was 265631 with an expiration date of 30-sep-2018.The ft4 ii reagent lot number used with the e801 module at the investigation site was 225159 with an expiration date of 31-may-2018.
 
Manufacturer Narrative
Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This caused the high ft4 ii and ft3 iii results and caused the difference in the tsh results.This interference is covered in product labeling.
 
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Brand Name
ELECSYS FT4 II ASSAY
Type of Device
RADIOIMMUNOASSAY, FREE THYROXINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7529992
MDR Text Key109371778
Report Number1823260-2018-01565
Device Sequence Number1
Product Code CEC
Combination Product (y/n)N
PMA/PMN Number
K131244
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 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07027397190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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