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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/15/2017

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), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The patient is suspected of having syndrome of inappropriate secretion of tsh (sitsh).The patient is aged in her 20s.This medwatch will apply only to ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh, refer to the medwatch with patient identifier (b)(4) for information related to ft3, and refer to the medwatch with patient identifier (b)(6) for information related to anti-tshr.The sample was initially tested on the customer's analyzer.The sample was then provided for investigation, where it was tested on a cobas 6000 e 601 module (e601), cobas 8000 e 602 module (e602), and 2 cobas e 411 immunoassay analyzers (e411).Refer to the attachment for all patient data.For the results followed by "(peg)", the patient sample was treated with polyethylene glycol (peg) prior to testing.There were no allegations of an adverse event occurring with the patient.The model and serial number of the customer's analyzer were asked for, but not provided.The e601 analyzer used for the investigation was serial number (b)(4).Ft4 reagent lot number 180429, with an expiration date of 09/30/2017 was used on this analyzer.The e602 analyzer used for the investigation was serial number (b)(4).Ft4 reagent lot number 180429, with an expiration date of 09/30/2017 was used on this analyzer.The e411 analyzers used for the investigation were serial numbers (b)(4).E411 serial number (b)(4) was used for testing of anti-tshr only.Ft4 reagent lot number 180429, with an expiration date of 09/30/2017 was used on e411 analyzer serial number (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.The presence of an interfering factor, most likely of an antibody nature, against one of the immunological components of the ft4, ft3, and anti-tshr assays was confirmed in the sample.This limitation is covered in product labeling.

• 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: 6420802
• MDR Text Key: 70524029
• Report Number: 1823260-2017-00604
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• 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