MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4; 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 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: asku.The event occurred in (b)(6).

Event Description

The customer complained of questionable results for the elecsys ft3 iii assay and ft4 when testing was performed on a cobas e602 analyzer with unknown serial number.The results generated at the customer's site did not match the results generated during the investigation of the patient's sample by the manufacturer.Refer to the attached data for all test results.The initial results were released outside the laboratory.No adverse event was reported.This report is for the ft4 reagent.Refer to the report with patient identifier (b)(6) for the ft3 reagent.The ft3 and ft4 results generated by the customer and by the investigation on an e601 analyzer were above the normal reference ranges of the tests.The results generated on the e411 analyzer during the investigation were around or within the upper limit of the normal reference ranges.Additional information was requested for the investigation but not provided.The issue may be caused by a biological component in the sample, but there was insufficient sample remaining to investigate the possibility.A general reagent issue can most likely be excluded.The investigation was unable to determine a specific root cause with the information provided.

Manufacturer Narrative

A sample from the patient was sent to the manufacturer for testing.The investigation confirmed the tsh, ft3, and ft4 results obtained by the customer.The investigation found an interfering factor to a constituent of the reagent was present in the patient's sample.This interference is covered 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
• 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: 6328891
• MDR Text Key: 67443123
• Report Number: 1823260-2017-00315
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: ASKU
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• 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