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

Catalog Number 12017709122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer initially questioned results for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii), elecsys pth immunoassay (pth) and elecsys t3 (t3) that showed different results using 3 different testing methods.The customer thinks there is an interference with the roche reagents.The high ft4 ii result is what made the customer investigate other thyroid results for this patient.The tsh result was normal and the elevated ft4 ii result did not match the patient¿s diagnosis since the patient does not have hypothyroidism.Three different samples from the patient were initially sent to 3 different sites using various testing methods.Based on the data provided, the results for tsh, ft4 ii and elecsys ft3 iii (ft3 iii) were erroneous and reported outside of the laboratory.The initial erroneous results for tsh, ft4 ii and ft3 iii were previously reported on manufacturer reports 1823260-2016-01872-00, 1823260-2016-01871-00 and 1823260-2016-01873-00 respectively.The customer obtained a new sample from the patient on (b)(6) 2017 and ran thyroid tests on the cobas 6000 e 601 module at the customer site and also sent it out to an external laboratory using a siemens system.The customer thinks the results from the siemens method are correct.Based on the data provided, additional erroneous results were identified for tsh and ft4 ii.New erroneous results were identified for elecsys t4 assay (t4), t3 and pth.The erroneous results were reported outside of the laboratory.Additional information on the tsh and ft4 ii results will be sent as a supplemental to those reports.This medwatch will cover t4.Refer to medwatch with patient identifier (b)(6) for information on the t3 erroneous results and medwatch with patient identifier (b)(6) for information on the pth erroneous results.Refer to the attached data for patient results.No adverse event occurred.The cobas 6000 e 601 module serial number was (b)(4).

Manufacturer Narrative

The patient sample from (b)(6) 2017 was submitted for investigation.Upon further investigation of the patient sample, a streptavidin interference was confirmed.This most likely caused the high t4 results.The reagent used to perform the tests contains streptavidin.This specific interference is addressed 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: 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: 6314380
• MDR Text Key: 67211359
• Report Number: 1823260-2017-00260
• 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: Physician
• 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: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12017709122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• 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: 16 YR