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

Catalog Number 06437290190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Manufacturer Narrative

Results for an additional ten patient samples with questionable results were provided.Of this data, only the ft4 results for one patient sample on (b)(6) 2014 were discrepant.The customer's results were 1.58 and 1.56 ng/dl.The initial investigation results were 1.64 and 1.60 ng/dl.The result by clia method was 2.2 ng/dl.Information concerning which result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.The patient's tsh result was 0.2 uiu/ml and ft3 result was 4.6 pg/ml.

Manufacturer Narrative

Four patient samples were submitted for investigation and an interference factor to streptavidin could be identified in three of the four samples.This interference is documented in product labeling.A specific root cause could not be identified for the fourth samples.Further clarification of the difference in the results received is not possible with available methods and the current state of the art.

Event Description

The customer received questionable thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3) results for an unknown number of patient samples.The customer tested the patient samples on a cobas 8000 e602 analyzer on an unknown date.As part of the investigation, the samples were tested on a modular pe analyzer, a cobas e411 analyzer and a centaur analyzer (clia).Of the data provided for 10 patient samples, only the results for four patient samples were discrepant.Refer to the attachment to the medwatch for all patient data.Information concerning which result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.The reagent lot numbers used by the customer were not provided.The ft4 reagent used on the modular pe analyzer was (b)(4) with expiration date july 2015.The ft4 reagent used on the cobas e411 analyzer was (b)(4) with expiration date april2015.Refer to the medwatchs with patient identifiers (b)(6) for the thyrotropin (tsh) and free triiodothyronine (ft3) assays.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4342826
• MDR Text Key: 12749861
• Report Number: 1823260-2014-10149
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2015

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: 06437290190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2015; 03/03/2015
• 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
• Patient Sequence Number: 1