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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 12/22/2014

Event Type  malfunction  

Event Description

The customer reported discordant results for thyroid tests.One patient sample was tested for thyrotropin(tsh), thyroxine (t4), free thyroxine (ft4), triiodothyronine (t3), and free triiodothyronine (ft3).The erroneous results were reported outside of the laboratory.This medwatch will cover t4.Refer to the attached data for the patient results.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results, medwatch with patient identifier (b)(6) for information on the ft4 erroneous results, medwatch with patient identifier (b)(6) for information on the erroneous t3 results and medwatch with patient identifier (b)(6) for the information on the erroneous ft3 results.The sample was initially tested on the e602 analyzer and then repeated on an abbott architect analyzer.Based on the clinical status of the patient, they expected results in the normal range for someone with a normal functioning thyroid.The original sample was then treated with hbt scantibodies tubes and tests were re-run on the e602 analyzer and repeated on the abbott architect analyzer.No adverse events were reported.The ft4 reagent lot number was 180539.The expiration date was requested but not provided.The ft3 reagent lot number was 180230.The expiration date was requested but not provided.The lot numbers and expiration dates for tsh, t3 and t4 were requested but not provided.The cobas e602 analyzer serial number was (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

The sample was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This specific interference is addressed in product labeling.

Manufacturer Narrative

Lot number was updated.

• Brand Name: T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4504120
• MDR Text Key: 5347722
• Report Number: 1823260-2015-00987
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• 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: 177623
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 01/22/2015
• 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
• Patient Sequence Number: 1
• Treatment: INSULIN
• Patient Age: 009 YR