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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

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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 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.From the information provided, a general reagent issue can be excluded.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable ft3 elecsys results for one patient sample from cobas e 601 module serial number (b)(4).The sample was retested on an architect analyzer and then submitted for investigation and tested on a cobas 8000 e 602 module.Refer to the attachment to the medwatch for all patent data.The customer reported out the results to a physician.
 
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Brand Name
ELECSYS FT3 III
Type of Device
RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key10922869
MDR Text Key243686892
Report Number1823260-2020-03042
Device Sequence Number1
Product Code CDP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K963127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2020
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 Model NumberFT3 G3
Device Catalogue Number06437206190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/05/2020
Initial Date FDA Received11/30/2020
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
Patient Age35 MO
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