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 Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

The expiration date was provided as 03/2017.This event occurred in (b)(6).

Event Description

The customer tested 1 patient sample from an unknown date with the elecsys tsh assay (tsh) and elecsys ft4 ii assay (ft4 ii).A patient sample from (b)(6) 2016 was tested on the customer's architect analyzer and the customer noticed a difference in the tsh, ft4 and ft3 results.The customer suspected an interference in the sample and sent the sample from (b)(6) 2016 in for investigation.The sample from (b)(6) 2016 was received and erroneous tsh, ft4 ii and elecsys ft3 iii (ft3 iii) results were identified between the customer's architect instrument and a modular pe analyzer and an e411 instrument used at the investigation site.The erroneous results were not reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.No adverse event occurred.The modular pe analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).A specific root cause could not be identified.There was not enough sample volume left to complete the investigation.

Manufacturer Narrative

A new sample from the patient was submitted for investigation.During the investigation, it was confirmed that the sample contained an immunoglobulin that reacts with the reagent which affects the sample results.Interferences are documented 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: 5939529
• MDR Text Key: 54324126
• Report Number: 1823260-2016-01336
• 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: 10/03/2016

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: 140865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• 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
• Patient Age: 24 YR