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 Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

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 (ft4), and the elecsys tsh assay (tsh) on a cobas 6000 e 601 module (e601).The erroneous results were reported outside of the laboratory.(b)(4).The customer initially tested the sample on their e601 analyzer.The sample was provided for investigation, where it was tested on a cobas 8000 e 602 module (e602) and a cobas e 411 immunoassay analyzer (e411).The sample was also repeated on a siemens centaur analyzer.No adverse events were alleged to have occurred with the patient.The e601 analyzer used at the customer site was serial number (b)(4).The e602 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 270341, with an expiration date of november 2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.A specific root cause could not be determined based on the provided information.There was no remaining sample volume available for further investigation.A general reagent issue can most likely be excluded.A factor which interferes with one or more components of the assays of roche and/or siemens may be present in the samples of this patient.

• 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: 7227357
• MDR Text Key: 98978180
• Report Number: 1823260-2018-00268
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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: 265631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• 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
• Patient Age: 16 YR