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 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned results from 1 patient sample tested for thyrotropin (tsh), elecsys ft4 ii assay (ft4 ii)a nd elecsys ft3 iii (ft3 iii).The customer provided the patient sample for investigation.Of the data provided, erroneous ft4 ii and ft3 iii results were identified between the customer's e602 analyzer, an e601 analyzer used at the investigation site and an e411 analyzer used at the investigation site.The initial results obtained at the customer site were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.No adverse event occurred.The e601 analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft3 reagent lot number used at the investigation site was 152267 with an expiration date of 05/31/2017.The ft4 reagent lot number used at the investigation site was 168540 with an expiration date of 07/31/2017.The serial number for the customer's e602 analyzer is not known.

Manufacturer Narrative

Upon further investigation of the patient sample, a streptavidin interference was confirmed.This most likely caused the high ft4 ii and ft3 iii results.The reagent used to perform the tests contains streptavidin.This specific interference is addressed in product labeling.For diagnostic purposes, the results should always be assessed in 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: 6113929
• MDR Text Key: 60448212
• Report Number: 1823260-2016-01811
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 11/01/2016
• 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