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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 Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).Medwatch field udi number: asku.
 
Event Description
The initial reporter stated they received discrepant results for three patient samples tested with the elecsys ft4 assay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.All samples were repeated on (b)(6) 2021.The reporter stated the issue occurred with a specific shipment of ft4 reagent.Controls were outside of range using this reagent and the reagent packs were found to have bubbles and heavy liquid residues in the lids.The first sample initially resulted in a ft4 value of >100.0 pmol/l, which repeated as 13.3 pmol/l.The second sample initially resulted in a ft4 value of >100.0 pmol/l, which repeated as 14.1 pmol/l.The third sample initially resulted in a ft4 value of >100.0 pmol/l, which repeated as 16.7 pmol/l.The serial number of the e 801 analyzer is (b)(4).
 
Manufacturer Narrative
A field service engineer performed planned maintenance after the event occurred.The investigation determined that the issue found by the customer (the reagent pack containing foam and beads in the lid) was the root cause of the issue.
 
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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 Key11806559
MDR Text Key249997562
Report Number1823260-2021-01409
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 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
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 Received04/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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