MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).(b)(4).

Event Description

The customer complained of thyroid test results that did not match the clinical condition of the patient.He said the patient had abnormal thyroid results with no clinical sign of thyroid disease.Test results for the elecsys tsh assay, ft4, and ft3 were compared to both the advia and abbott methods.The doctor suspected an interference and also performed peg precipitation studies on tsh with the roche and abbott methods.Refer to the attached data.There was no allegation of an adverse event.Testing was performed on a cobas 6000 e 601 module; the serial number was not provided.(b)(6).

Manufacturer Narrative

The patient's sample was submitted for investigation.No interfering factors to the reagent were found.The patient's sample was tested with multiple analyzers.The results obtained by the customer were not confirmed.A sample tube mix-up, either of the sample tested at the customer's site or the sample sent by the customer for investigation, may have occurred.Based on the information provided, a general reagent issue can most likely be excluded.

• Brand Name: ELECSYS FT4
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: 6312499
• MDR Text Key: 66879064
• Report Number: 1823260-2017-00249
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• 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: 32 YR