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 10/23/2014

Event Type  malfunction  

Event Description

The customer received questionable free thyroxine (ft4) results for one patient.The ft4 result from the analytical e module analyzer serial number (b)(4) was 31.60 pmol/l.On (b)(6) 2014 the sample was sent to another laboratory and tested on an abbott architect and the result was 14.5 pmol/l.All of the results were reported outside the laboratory.The patient was not adversely affected.Samples from the patient were submitted for further investigation.

Manufacturer Narrative

For the medication of hydroxycobalamine: "for the medication of hydroxycobalamine last dose (b)(6) 2014, commenced 2008, inject every 3/12" this event occurred in (b)(6).(b)(4).

Manufacturer Narrative

Samples from the patient were submitted for further investigation and an unspecific interfering factor was identified.Interference is described in product labeling.

• 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) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4267149
• MDR Text Key: 5028143
• Report Number: 1823260-2014-09153
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• 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: 178388
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/10/2014
• 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: HYDROXYCOBALAMINE
• Patient Age: 061 YR
• Patient Weight: 93