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 09/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ft4 ii assay and elecsys tsh assay results for two samples from on patient from two cobas e602 analyzers and suspected the possible presence of heterophilic antibodies.Refer to the attachment to the medwatch for all patient data.This medwatch is for the ft4 assay.Refer to the medwatch with (b)(6) for the tsh assay.The results were reported to the clinicians.The patient was not adversely affected.As no sample material from the patient could be provided for further investigation, a specific root cause could not be determined.From the provided information, a general reagent issue was not detected.

Manufacturer Narrative

A new sample was collected from the patient on (b)(6) 2016 and generated questionable results.

Manufacturer Narrative

Two samples from the patient were submitted for investigation.A specific root cause could not be determined.The testing confirmed the customer's results as the ft4 results generated were above the reference range.No interfering factors were detected in the samples.For diagnostic purposes, the results should always be assessed win conjunction with the patient's medical history, clinical examination, and other findings.

• 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: 6010651
• MDR Text Key: 56969287
• Report Number: 1823260-2016-01537
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• 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?: No
• Date Manufacturer Received: 09/19/2016
• 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