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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

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

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer questioned results from 4 samples from the same patient tested for elecsys ft3 iii (ft3 iii), elecsys ft4 ii assay (ft4 ii) and elecsys tsh assay (tsh).The customer provided the patient samples for investigation.Of the data provided, erroneous ft4 ii results were identified between the customer's cobas 6000 e 602 module, a centaur analyzer and an e602 module used at the investigation site.The erroneous results were not reported outside of the laboratory.Refer to attached data for the patient results.There was no allegation that an adverse event occurred due to results from the device.The samples from this patient had been stored frozen for approximately 2 years.The customer¿s e602 module (b)(4).The e602 module (b)(4).The ft4 ii reagent lot number used at the investigation site was 265631 with an expiration date of sep-2018.A specific root cause was not identified.Additional information was requested for investigation but was not provided.The differences in the customer¿s results compared to the results from the e602 module used at the investigation site may be due to sampling aging effects.The original samples were from (b)(6) and (b)(6) 2016 and were subjected to multiple freeze/thaw cycles.When comparing results from roche analyzers to the siemens method, it should be taken into account that assays from different manufacturers can generate different results.This relates to the overall setup of the assays, the antibodies used and differences in materials/methods and the standardization method used.Based on the information available, a general reagent issue can most likely be excluded.

• 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: 7128190
• MDR Text Key: 95774275
• Report Number: 1823260-2017-02989
• 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
• Report Date: 12/19/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/19/2017
• 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