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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay, and the elecsys tsh assay (tsh).It was asked, but it is not known if erroneous results were reported outside of the laboratory.This medwatch will cover ft4 only.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3 and refer to the medwatch with patient identifier (b)(6) for information related to tsh.The sample was initially tested at the customer site on an abbott analyzer and an e602 analyzer.The sample was provided for investigation, where it was tested on an e601 (or modular-pe) analyzer and an e411 analyzer.It was not clear if it was an e601 analyzer used for investigation or if it was a modular-pe analyzer.A clarification has been requested.The patient was not adversely affected.The e602 analyzer serial number was asked for, but not provided.The e601 (or modular-pe) analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 168540, with an expiration date of july 2017.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 168540, with an expiration date of july 2017.

Manufacturer Narrative

Analyzer serial number (b)(4) used for investigation purposes has been confirmed to be an e601 analyzer.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample determined that it contained an interferent to the streptavidin present in the ft3 and ft4 reagents.This limitation is covered 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 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: 6064439
• MDR Text Key: 58771348
• Report Number: 1823260-2016-01668
• 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,Followup,Followup
• Report Date: 11/29/2016

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 Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/31/2016; 11/29/2016
• 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