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

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

The customer received questionable free thyroxine (ft4) results for one patient sample from cobas e601 serial number (b)(4).The initial result was 7.49 ng/dl and was reported outside the lab.The doctor questioned the result and the sample was repeated with a result of 7.63 ng/dl.The customer sent the sample to a reference lab where it was tested by chemiluminescense and the result was 1.25 ng/dl.The result from the reference laboratory was believed to be correct.The patient was not adversely affected.The field service representative determined the issue was with the patient sample.He ran performance testing.All controls were acceptable and the system was performing to specifications.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Manufacturer Narrative

Additional information was received that the analyzer used at the reference laboratory was an abbott architect.A specific root cause could not be identified as no sample was available for further investigation.Based on analysis of the provided calibration and qc data, a general reagent issue was excluded.

• 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: 4953377
• MDR Text Key: 20040469
• Report Number: 1823260-2015-03892
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 06437281160
• Device Lot Number: 18347401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/15/2015
• 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
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE