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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received questionable results for a total of 50 patient samples tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).Of the 50 samples, the customer provided data for a total of 24 patient samples that had erroneous tsh, ft3, and ft4 results.It was asked, but it is not known if the erroneous results were reported outside of the laboratory.The customer suspects that the samples contain interfering factors to the roche tsh, ft3, and ft4 assays.This medwatch will apply to the ft4 assay.(b)(4).Samples were tested on the e602 analyzer, a delfia analyzer, and a beckman coulter access analyzer.No adverse events were alleged to have occurred with the patients.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.

Manufacturer Narrative

All 24 samples were provided for investigation.An interfering factor against components used in the ft3 and ft4 assays was found in the following samples: 2, 5, 6, 7, 8, 10,11,12,13, 16, 18, 19, 20, 21, 22, 23, and 24.This limitation is covered in product labeling.No interfering factor was found in samples 1, 3, 4, 9, 14, 15, and 17.

Manufacturer Narrative

Upon further investigations, the biotin concentration was measured in samples 1, 3, 9, 14, and 17.Sample 9 was found to have a very high biotin concentration at 869 ng/ml.This concentration is far above the concentration threshold specified in product labeling for the ft4 assay (no interference up to 20 ng/ml).This high biotin concentration most likely caused the discrepant high ft4 result of sample 9.

• 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: 6951526
• MDR Text Key: 90546755
• Report Number: 1823260-2017-02326
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• 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
• Date Manufacturer Received: 09/28/2017
• 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