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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer received questionable thyroid results for one patient from a cobas 6000 e 601 module.The serial number was requested but was not provided.The patient has dwarfism and had been injected with recombinant human growth hormone beginning in (b)(6) 2017.An interference was suspected as the results portray hyperthyroidism however the patient had no thyroid symptoms and appeared normal.The results of the patient's thyroid function tests were normal on (b)(6) 2018.However, with samples from (b)(6) 2018, the elecsys ft3 iii and elecsys ft4 ii assay concentrations were both increased.The samples were tested with the beckman, siemens, and abbott methods and the results were discrepant for ft3, ft4, elecsys tsh assay, and roche diagnostics cobas elecsys anti-tpo.This medwatch is for the ft4 assay.Refer to the medwatchs with the following patient identifiers for the other assays involved: (b)(6).No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

A sample was requested for investigation but cannot be provided.The investigation was unable to find a definitive root cause.

• 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: 7800846
• MDR Text Key: 117905985
• Report Number: 1823260-2018-02791
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• 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: 09/04/2018

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: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR