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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for five samples from the same patient tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), and the elecsys ft4 ii assay (ft4) on a cobas 6000 e 601 module (e601).The results were said to not be consistent with the clinical picture of the patient.This medwatch will cover ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3 and refer to the medwatch with patient identifier (b)(6) for information related to tsh.Refer to the attachment for all patient data.Each sample was initially tested on the customer's e601 analyzer.The fifth sample was repeated on a siemens vista analyzer since results from the e601 analyzer were said to not be consistent with the patient's clinical picture.The physician considered the results from the siemens vista analyzer to more reliably match the patient's clinical picture.The patient was not adversely affected.The serial number of the used e601 analyzer was asked for, but not provided.The reagent expiration dates were asked for, but not provided.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations have determined that the sample contains an interferent to the streptavidin present in the ft3, ft4, and tsh reagents.This limitation is covered in product labeling.This interfering factor most likely caused the falsely elevated values of the ft4 and ft3 assays, as well as the falsely decreased value for the tsh assay.

• Brand Name: FT4, FREE THYROXINE
• 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: 6124230
• MDR Text Key: 60878565
• Report Number: 1823260-2016-01843
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

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: 06437281190
• Device Lot Number: 140865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• 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
• Treatment: SUMATRIPTAN
• Patient Age: 37 YR