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

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).The specific date of the event was asked for, but it is not known.The customer stated that the patient had a ft4 result of 15.3 pmol/l in (b)(6) 2014.The units of measure used for ft4 were asked for, but not provided.It was stated that the patient had the following ft4 results in (b)(6) 2015: 71.9 pmol/l, 76 pmol/l, 75.6 pmol/l, and 92.2 pmol/l.It was stated that the last sample was also measured on an abbott system and the ft4 result was 14.0 pmol/l.The units of measure are assumed to be pmol/l based upon the normal reference range of the assay provided for the ft3 results noted.Typically the same units of measure are used for both assays.It was asked, but it is not known, if any erroneous results were reported outside of the laboratory.The patient was not adversely affected.A specific root cause could not be determined as patient sample was not available for further investigation.Additional information for further investigation was requested but was not provided.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 6120486
• MDR Text Key: 60653259
• Report Number: 1823260-2016-01829
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1