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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer initially questioned results for 1 patient tested for elecsys ft4 ii assay (ft4ii) on a cobas 8000 e 602 module.The patient¿s thyroid function was examined on (b)(6) 2016 and (b)(6) 2017.The thyroid results from the e602 module at the customer site for these dates were very similar.Most of the thyroid tests showed positive results, however the patient had no significant thyroid discomfort.The patient went to a different hospital on (b)(6) 2016 where a siemens instrument was used and her thyroid results were normal.The customer took the patient sample from (b)(6) 2017 and repeated it on a beckman instrument and another e602 instrument at another site and erroneous ft4 ii, thyrotropin (tsh), triiodothyronine (t3), thyroxine (t4), ft3 ¿ free triiodothyronine (ft3) and antibodies to thyroid peroxidase (anti-tpo) results were identified.This medwatch will cover t4.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous results, medwatch with patient identifier (b)(6) for information on the tsh erroneous results, medwatch with patient identifier (b)(6) for information on the t3 erroneous results, medwatch with patient identifier (b)(6) for information on the ft3 erroneous results and medwatch with patient identifier (b)(6) for information on the anti-tpo erroneous results.Refer to attached data for patient results.No adverse event occurred.The e602 module serial number was (b)(4).

Manufacturer Narrative

The customer stated instrument maintenance and sample processing is according to specifications.Quality controls are run daily and have been acceptable.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.The patient sample cannot be provided for investigation.Based on the information available for investigation, a general reagent issue can most likely be excluded.The differences between the roche results and the results from other manufacturers may be due to assay interfering factors.These interfering factors may affect the thyroid assays from roche and other manufacturers differently.However, since the patient sample cannot be provided, this cannot be confirmed.

• Brand Name: ELECSYS T4 ASSAY
• 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: 6308606
• MDR Text Key: 66769111
• Report Number: 1823260-2017-00237
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• 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: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• 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
• Patient Age: 55 YR