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 04/16/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for thyrotropin (tsh), ft3 - free triiodothyronine (ft3 iii) and free thyroxine (ft4 ii).It is not known if erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.The initial tsh result from the cobas 8000 core unit was 6.09 uiu/ml.The sample was repeated on a centaur system and the result was 69.7 uiu/ml.The initial ft3 iii result from the cobas 8000 core unit was 10.16 pg/ml.The sample was repeated on a centaur system and the result was 1.3 pg/ml.The initial ft4 ii result from the cobas 8000 core unit was 2.77 ng/dl.The sample was repeated on a centaur system and the result was 0.5 ng/dl.No adverse event occurred.The cobas 8000 core unit serial number was (b)(4).It was noted that peg precipitation tests gave low recovery results for the ft3 iii and ft4 ii parameters.No specific values were provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the information provided, pre-analytical issues can most likely be excluded.

Manufacturer Narrative

The customer indicated that the patient sample involved in this case is a new event from the same patient reported in the following report numbers: 1823260-2015-04362-00, 1823260-2015-04363-00, 1823260-2015-04364-00.The customer used an e602 analyzer.The serial number was not provided.The patient sample was submitted for preliminary investigation.The sample was tested on an e411 analyzer used at the investigation site and a modular pe analyzer used at the investigation site.The tsh result from the modular pe analyzer was 5.66 uiu/ml.The result from the e411 analyzer was 6.09 uiu/ml.The ft4 ii result from the modular pe analyzer was 2.02 ng/dl.The result from the e411 analyzer was 1.13 ng/dl.The ft3 iii result from the modular pe analyzer was 8.13 pg/ml.The result from the e411 analyzer was 4.44 pg/ml.Based on the available data, a general reagent issue at the customer site can most likely be excluded.A sample from this patient was submitted for investigation in a previous case where a streptavidin interfering factor was identified.This specific interference is addressed in product labeling.This interfering factor is most likely also in the sample addressed in the current case.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.

• 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: 5630434
• MDR Text Key: 44410917
• Report Number: 1823260-2016-00588
• 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,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

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?: No
• Initial Date Manufacturer Received: 04/16/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• 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: 85 YR