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 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable results from 1 patient sample tested for thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3) on a cobas 8000 analyzer (serial number unknown).The serial number of the analyzer was requested but not provided.These results were reported outside the laboratory and were questioned by a physician who stated that the elecsys thyroid tests were unbalanced and asked for an investigation.The sample from the patient was submitted for investigation and tested on a analytical e module analyzer and a cobas e411 analyzer.Of the data provided, only the results for ft4 and ft3 were erroneous.Refer to the attachment to the medwatch for all patient results.All results from the investigation will be reported to the customer.This medwatch will cover ft4.Refer to medwatch with (b)(6) for information on the ft3 erroneous results.No adverse event was reported.The mod-pe analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).These were the analyzers used at the investigation site.A specific root cause could not be identified as sample material from the patient was not available for further investigation.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 5836700
• MDR Text Key: 50847247
• Report Number: 1823260-2016-01093
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial
• Report Date: 08/01/2016

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 Expiration Date: 08/31/2016
• Device Catalogue Number: 06437281190
• Device Lot Number: 187609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 08/01/2016
• 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