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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of questionable results for 1 patient sample tested for elecsys tsh assay, elecsys t4 assay (t4), elecsys t3 (t3), elecsys ft3 iii (ft3 iii), elecsys ft4 ii assay, roche diagnostics cobas elecsys anti-tpo (anti-tpo), and roche diagnostics elecsys anti-tg.The patient samples were tested on two different cobas 8000 e 602 modules and compared to an abbott system."(b)(6)" cobas e602 serial number was (b)(4) and "(b)(6)" cobas e602 serial number was (b)(4).Of the data provided, there were reportable malfunctions for t4, t3, ft3 iii, and anti-tpo.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The patient has no clinical symptoms of thyroid disease.An interfering factor is believed to present, but a patient sample can not be shipped for further analysis due to (b)(6) export customs.Medwatches for this event include those with (b)(6).The investigation is currently ongoing.

Manufacturer Narrative

Further analysis determined that a general reagent issue is can most likely be excluded.Since the patient sample can not be made available for interference testing, the investigation was unable to find a definitive root cause.

• 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: 7279701
• MDR Text Key: 100551750
• Report Number: 1823260-2018-00492
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• 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: 248077
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• 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: 56 YR