MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer questioned results for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii), elecsys pth immunoassay (pth) and triiodothyronine (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 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.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and medwatch with patient identifier (b)(6) for information on the ft3 iii 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

A specific root cause could not be identified.A sample from the patient was requested for investigation but could not be provided.Based on the information available, a general reagent issue can most likely be excluded.An interference may be present in the sample, but this cannot be confirmed since the sample was not provided for investigation.

Manufacturer Narrative

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 elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii), t4 assay (t4), t3assay (t3) and pth immunoassay (pth).The erroneous results were reported outside of the laboratory.Relevant tests/lab data was updated.Refer to manufacturer report 1823260-2017-00260-00 for the erroneous t4 results.Refer to manufacturer report 1823260-2017-00261-00 for the erroneous t3 results.Refer to manufacturer report 1823260-2017-00262-00 for the erroneous pth results.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 ft4 ii results.The reagent used to perform the tests contains streptavidin.This specific interference is addressed in product labeling.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 6134988
• MDR Text Key: 61293802
• Report Number: 1823260-2016-01871
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131244
• 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/13/2016; 02/09/2017
• 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