MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH, THYROTROPIN; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number ASKU

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2009

Event Type  malfunction  

Manufacturer Narrative

A specific root cause could not be determined.From the information provided, a general reagent issue is not likely.Samples were requested for investigation, but could not be provided.

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that the drug voltaren may have an effect on free triiodothyronine (ft3) measurements and provided some data from patients who were prescribed voltaren.Voltaren was prescribed for the patients, but it is not known if the patients actually took the drug.The voltaren medication was prescribed as a medicine to be taken when the patients were in pain.Data was provided for a total of eleven samples from eight different patients.The samples were tested using the roche ft3, free thyroxine (ft4), and thyrotropin (tsh) methods on an e moodule and also the centaur analyzer method of the same assays.Of the data provided, six samples from six different patients had erroneous results for ft3 when compared to the centaur analyzer method.One of the six same samples had an erroneous result for tsh when compared to the centaur analyzer method.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.This medwatch will only cover the tsh assay.(b)(4).Patient identifier of (b)(6) for information on the ft3 assay.The patient sample initially had a tsh result of 4.49 uiu/ml and 7.3 pg/ml for ft3 on an e module on (b)(6) 2009.The sample was tested on a centaur analyzer and resulted as 6.3 uiu/ml for tsh and 2.3 pg/ml for ft3.The patient was not adversely affected.The e module serial number was asked for, but not provided.

• Brand Name: TSH, THYROTROPIN
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 4323352
• MDR Text Key: 12826833
• Report Number: 1823260-2014-09882
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• 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
• Report Date: 02/10/2015

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• 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
• Treatment: VOLTAREN