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 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned the high elecsys ft4 ii assay results received for an unknown number of patient samples from three cobas e602 analyzers.Only the serial number of one analyzer, (b)(4), was provided.The customer felt the high results were discrepant and could not be explained by the clinical condition of the patients.Currently when they question a result, they send the sample to be tested on another platform (abbott or siemens).Due to the increase in unexplained high results, the endocrinologists were getting more referrals, with more patients having to be redrawn.Usually patients over age 70 were affected, but the samples in question originated from various aged patients.The customer felt there has been a drastic increase in these incidents in the last six months.Data were provided for 29 patient samples.Information concerning if any erroneous result was reported outside the laboratory was requested but it was not unknown.The patients were not adversely affected.The customer stated there was a general high bias with the assay and suspected possible interference with the patient matrix and assay components.

Manufacturer Narrative

A specific root cause could not be determined.From the information provided, a general reagent issue could most likely be excluded.The provided data did not demonstrate a sudden shift or trend in the patient results, but did show a high number of results greater than the reference range.Most of the results in question were from elderly patients.Ft4 results in elderly patients may be higher in relation to the top of the normal reference range.It was recommended the customer establish their own reference ranged based on their specific patient population.

• 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: 6053418
• MDR Text Key: 58424655
• Report Number: 1823260-2016-01620
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• 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?: Yes
• Date Manufacturer Received: 10/10/2016
• 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
• Patient Age: 31 YR