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

Catalog Number 11731297122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer received questionable thyroid results for one patient sample from cobas 8000 cobas e 602 module serial number (b)(4) when compared to the results from an abbott architect.The results from the cobas e602 did not correlate with patient symptom and an interference was suspected.This medwatch is for elecsys ft4 assay.Refer to the following medwatch with patient identifier for the other assays involved: elecsys tsh assay=(b)(6); elecsys t3 assay=(b)(6); elecsys t4 assay=(b)(6); elecsys ft3=(b)(6).The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The customer provided 3 samples from one patient for investigation.The investigation found an interfering factor against steptavidin present in the patient's sample.This interference is covered in product labeling.

• Brand Name: ELECSYS FT4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7965345
• MDR Text Key: 125284202
• Report Number: 1823260-2018-03667
• 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
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11731297122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR