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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable thyroid results for one patient sample from a cobas 8000 e 602 module and suspected interference.The serial number of the involved cobas 8000 e 602 module was requested but was not provided.The sample was submitted for investigation and was tested on a cobas 8000 e 602 module and a cobas e 411 immunoassay analyzer.Of the data provided, only the results for elecsys ft3 iii and elecsys ft4 ii assay were discrepant.Refer to the attachment to the medwatch for all patient data.The first results for the sample were automatically reported to the physician.There was no allegation of an adverse event.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.From the information provided, a general reagent issue could most likely be excluded.The difference in the results was most likely due to a biological component present in the sample that may react with the reagent.As insufficient sample material remained, further investigation was not possible.Refer to the medwatch with a1 patient identifier (b)(4) for the ft3 assay.

Manufacturer Narrative

The customer provided patient sample for testing.No interfering factor was identified.No product problem was found.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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 Key: 6903991
• MDR Text Key: 89495473
• Report Number: 1823260-2017-02154
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1