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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 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The investigation is ongoing.
 
Event Description
The initial reporter received questionable elecsys ft3 iii results for 1 patient sample and questionable elecsys ft3 iii results and elecsys ft4 iii assay for 1 patient sample on cobas e 801 module, serial number (b)(4).This medwatch covers the alleged results for the ft3 assay.Please refer to medwatch mdr-47505 for the alleged ft4 assay results for 1 of the patient samples.See highlighted section of attachment "cn551012.Pdf" for patient results.The results were not reported outside of the laboratory.
 
Manufacturer Narrative
The customer's sample was returned for investigation.The sample was investigated with a dedicated research toolbox to detect streptavidin interfering factors.A decreased amount of counts was generated with the kit version that contains an additional amount of a given streptavidin blocking agent.This does not indicate the presence of a streptavidin interfering factor.With a research version of the ft3 assay that contains an additional amount of a given iep (interference eliminating protein), a non-significant increase of the ft3 value was measured compared to the value generated with the commercially available assay.Once again, this does not indicate that an streptavidin interfering factor is available in the sample analyzed.Although no interfering factor could be identified during the analysis of the sample, an interfering factor may have been available in the sample.The effect of the latter on the value of the ft3 assay may have been minimalized by the different freeze/thaw cycles of the sample concerned.From the information provided and the analysis thereof, a general reagent issue most likely can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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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
MDR Report Key10691213
MDR Text Key227988034
Report Number1823260-2020-02567
Device Sequence Number1
Product Code CDP
Combination Product (y/n)N
PMA/PMN Number
K963127
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 12/22/2020
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 Number07027362190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/16/2020
Supplement Dates Manufacturer Received09/23/2020
Supplement Dates FDA Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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