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 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 1 patient sample tested for ft3 - free triiodothyronine (ft3 iii) and free thyroxine (ft4 ii).Based on the clinical status of the patient, they expected results in the normal range for someone with a normal functioning thyroid.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.The ft3 iii result from the e 170 analyzer was 9.23 pmol/l.The sample was repeated and the result was 9.10 pmol/l.The ft4 ii result from the e 170 analyzer was 25.12 pmol/l.It is not known if an adverse event occurred.No adverse event was reported.The e 170 analyzer serial number was (b)(4).

Manufacturer Narrative

The patient sample was submitted for investigation.During the preliminary investigation the ft3 and ft4 results of the customer were confirmed.An interfering factor was not identified.The sample was further investigated by sending it out to an external laboratory where it was tested on a siemens instrument.The ft3 and ft4 values were in line with the values received by the customer and the results received by roche during the preliminary investigation.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5232250
• MDR Text Key: 31457006
• Report Number: 1823260-2015-04572
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/29/2015

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: Other
• Device Catalogue Number: 06437281190
• Device Lot Number: 187609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• 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