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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE

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ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE Back to Search Results
Catalog Number 06437281190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2014
Event Type  malfunction  
Event Description
The customer received questionable free thyroxine (ft4) results for three samples from one patient from the cobas e601 analyzer serial number (b)(4).Sample 1 initial result was 5.33 ng/dl and the result from the architect analyzer was 2.55 ng/dl.On (b)(6) 2014, sample 2 initial result was 5.96 ng/dl and the result from the architect analyzer was 2.71 ng/dl.On (b)(6) 2014, sample 3 initial result was 4.14 ng/dl and the result from the architect analyzer was 2.28 ng/dl.Information concerning which result was reported outside the laboratory was requested, but was not provided.The patient was not adversely affected.Sample 3 was submitted for further investigation.
 
Manufacturer Narrative
This event occurred in (b)(6).
 
Manufacturer Narrative
A specific root cause could not be identified.Testing of sample 3 confirmed the customer's result and found no interfering factor.Further clarification of the difference in the results between the analyzers is not possible with available methods and the current state of the art.
 
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Brand Name
FT4, FREE THYROXINE
Type of Device
RADIOIMMUNOASSAY, FREE THYROXINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 6830 5
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key4334758
MDR Text Key5248643
Report Number1823260-2014-10029
Device Sequence Number1
Product Code CEC
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K961489
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/04/2015
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 Catalogue Number06437281190
Device Lot Number179279
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Initial Date Manufacturer Received 12/10/2014
Initial Date FDA Received12/16/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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