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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable free thyroxine (ft4) and free triiodothyronine (ft3) results for one patient sample.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.The results from cobas e601 analyzer serial number (b)(4) were: ft4: 3.0 pmol/l, ft3: 0.4 pmol/l.The results were reported to the physician.Since the results did not fit the clinical picture, the physician asked for a re-analysis of the sample.On a later date, the sample was tested on a vitros analyzer and the results were: ft4: 32.5 pmol/l, ft3: 5.29 pmol/l.The results from the vitros analyzer were believed to be correct.A new sample from the patient was tested on the cobas 09/19/2015 and the results were: ft4: 3.1 pmol/l, ft3: 0.4 pmol/l.The patient was not adversely affected.

Manufacturer Narrative

A specific root cause could not be identified as sample from the patient was not available for further investigation.Additional information for further investigation was requested but was not provided.It was noted the customer was not following the recommended calibration frequency.

• 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: 5217357
• MDR Text Key: 30998099
• Report Number: 1823260-2015-04518
• 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: 12/16/2015

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: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• 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
• Patient Age: 067 YR