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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable elecsys tsh assay and elecsys ft4 assay results for one patient that had been treated with qizenday biotin and suspected interference.Of the data provided, only the ft4 results were a reportable malfunction.The actual date of testing was not known.The initial ft4 result was >77.69 ng/l and the result from an abbott analyzer was 25 ng/l.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The customer used cobas e 602 module serial number (b)(4).

Manufacturer Narrative

A general reagent issue can be excluded.As no sample was available for investigation, further investigation could not be done.The investigation could not determine a root cause.

Manufacturer Narrative

Na.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7724307
• MDR Text Key: 115577257
• Report Number: 1823260-2018-02254
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

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 Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 06/26/2018; 06/26/2018
• Supplement Dates FDA Received: 08/09/2018; 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR