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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).It was stated that the patient was prescribed the thyradin-s medication in (b)(6) 2015.(b)(4).

Event Description

It was reported that there were erroneous results for one patient sample tested for free thyroxine (ft4) on an e411 analyzer.The sample was initially tested at the customer site on (b)(6) 2015 on an e601 analyzer.The results from the customer site were reported to the physician.For investigation, the sample was tested on a modular pe system on (b)(6) 2015 and an e411 analyzer on (b)(6) 2015.The results from the e411 analyzer were lower when compared to all other results.Refer to the attachment for the specific sample results.The patient was not adversely affected.The ft4 reagent lot number used on the e411 analyzer was 184927, with an expiration date of 03/31/2016.A specific root cause could not be determined based on the provided information.A general reagent issue is not likely.

Manufacturer Narrative

The sample in question has also been repeated on a centaur analyzer for the ft4, free triiodothyronine (ft3), and thyrotropin (tsh) tests.When comparing the customer's results to the results from the centaur analyzer, the sample now has erroneous result for ft3 and tsh in addition to the ft4 results.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.The sample in question resulted as 1.7 ng/dl for ft4, 3.8 pg/ml for ft3, and "below 0.1" uiu/ml for tsh when tested on the centaur analyzer.The serial number of the e601 analyzer used at the customer site was asked for, but not provided.The modular-pe analyzer used for investigation purposes was serial number (b)(4).Ft4 reagent lot number 184927, with an expiration date of 03/31/2016 was used on this analyzer.The e411 analyzer used for investigation purposes was serial number (b)(4).Ft4 reagent lot number 184927, with an expiration date of 03/31/2016 was used on this analyzer.

Manufacturer Narrative

Further investigations of the sample could not determine a specific root cause.There was no remaining sample volume left for further investigations.It was determined that there is most likely no interference due to the dyslipidemia of the patient.A further clarification of the result difference between the different analyzers is not possible with available methods and the current state of the art.

• 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: 5334329
• MDR Text Key: 34691077
• Report Number: 1823260-2015-06147
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2016

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/04/2016; 04/22/2016
• 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
• Patient Age: 63 YR