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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2017

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 the elecsys tsh assay (tsh) and the elecsys ft4 ii assay (ft4) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e module).It was asked, but it is not known if an erroneous result was reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient sample data.The sample was tested on the customer's e module and an architect analyzer.The e module serial number was (b)(4).

Manufacturer Narrative

The patient sample was provided for investigation, where it was tested on a cobas 8000 e 602 module (e602).The results from this analyzer were < 0.005 uiu/ml for tsh, 4.12 ng/dl for ft4, and 5.46 pg/ml for ft3.The e602 analyzer serial number was (b)(4).The ft4 reagent lot number used on this analyzer was 215455, with an expiration date of march 2018.With reference to the ft4 values from the different methods, all values are above the normal reference ranges of the respective assays.To the differences of the ft4 values generated with the analyzers from roche diagnostics and abbott, it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.

• 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: 6868757
• MDR Text Key: 87315743
• Report Number: 1823260-2017-02002
• 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
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• 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?: No
• Date Manufacturer Received: 08/25/2017
• 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