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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE
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ROCHE DIAGNOSTICS ELECSYS FT4 ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE Back to Search Results
Catalog Number ASKU
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).(b)(4).
 
Event Description
The customer questioned thyroid results for 6 patient samples tested on a cobas e801 module.The customer provided the patient samples for investigation where discrepant results were identified for elecsys ft3 iii (ft3 iii), tsh and ft4 between the customer's e801 module, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site and the siemens centaur method.It is not known if the initial results from the customer site were reported outside of the laboratory.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the tsh results.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The e602 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used with the e602 module was 304692 with an expiration date of 31-jan-2019.The ft4 iii reagent lot number used with the e411 analyzer was 304692 with an expiration date of 31-jan-2019.The ft4 iii reagent lot number used with the e801 module at the investigation site was 304694 with an expiration date of 31-jan-2019.
 
Manufacturer Narrative
There was not enough sample material remaining to complete the investigation.Based on the data provided, a general reagent issue can be excluded.The investigation was unable to find a definitive root cause.
 
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Brand Name
ELECSYS FT4 ASSAY
Type of Device
RADIOIMMUNOASSAY, FREE THYROXINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7818071
MDR Text Key118405585
Report Number1823260-2018-02868
Device Sequence Number1
Product Code CEC
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 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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