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

Catalog Number 07027397190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable thyroid results for one patient from cobas e 801 module (b)(4).The sample was repeated on a siemens analyzer.The initial elecsys ft4 ii assay result was 28.1 pmol/l and repeat result was 16.1 pmol/l.The initial elecsys tsh assay result was 1.28 miu/l and the repeat result was 2.56 miu/l.The initial elecsys ft3 result was 12.2 pmol/l and the repeat result was 4.7 pmol/l.This medwatch is for the ft4 assay.Refer to the medwatchs with patient identifiers (b)(6) for the other assays involved.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

Sample from the patient was submitted for investigation.The sample was found to contain an immunoglobulin that reacts with the reagent and affects the sample results.This interference is documented in product labeling for the assay.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8168555
• MDR Text Key: 130489473
• Report Number: 1823260-2018-04902
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROPANOLOL; VALIUM; ZYPREXA; PROPANOLOL; VALIUM; ZYPREXA
• Patient Age: 37 YR