MAUDE Adverse Event Report: ROCHE DIAGNOSTICS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number 12017709122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

The customer reported that they received erroneous results for one patient sample tested for thyrotropin (tsh), triiodothyronine (t3), and thyroxine (t4).The customer states that the patient has had questionably high t3 and t4 test results since the beginning of (b)(6) 2013.This medwatch will cover t4.Please refer to the medwatch with patient identifier (b)(6) for information related to t3 and refer to the medwatch with patient identifier (b)(6) for information related to tsh.A sample from (b)(6) 2015 was initially tested at the customer site, "mgh", on an e601 analyzer.The results from the e601 analyzer were reported to the physician, who did not believe the results.The results did not match the patient's clinical presentation, so the sample was sent to a reference laboratory for additional testing.The sample was then tested at the reference laboratory, "srh", on an abbott architect analyzer.The results from the abbott architect analyzer were believed to be correct.Refer to the attachment for the sample results.The patient was not adversely affected.The e601 analyzer serial number was (b)(4).The customer declined a service visit and believed the issue to be patient specific.The customer alleged the erroneous results were due to interference by exogenous biotin taken by the patient.A specific root cause could not be determined based on the provided information.The patient sample was requested for investigations, but could not be provided.

• Brand Name: T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 5436491
• MDR Text Key: 38228592
• Report Number: 1823260-2016-00150
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 12017709122
• Device Lot Number: 17762302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• 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: 37 YR