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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they had erroneous results for three samples from three different patients tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), roche diagnostics cobas elecsys anti-tpo (anti-tpo), and the elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 602 module (e602).This medwatch will apply to the ft4 assay.Please refer to the following medwatches with a1.Patient identifiers for information related to the other assays: tsh = pt-(b)(6).Ft3 = pt-(b)(6).Anti-tpo = pt-(b)(6).Anti-tshr = pt-(b)(6).Refer to the attachment for all patient data.Results highlighted in yellow are erroneous.All erroneous results were reported outside of the laboratory.Dates listed next to result values indicate the testing date.All patients have multiple sclerosis and are treated with qizenday medication (biotin).The customer alleges that biotin interference caused an issue with the roche assay recovery.False hyperthyroidism was diagnosed for these 3 patients based on the roche assay results and thus they were treated with inappropriate treatment.The affected samples were tested with alternate methods which do not use biotin.No adverse events were alleged to have occurred with the patients.The serial number of the e602 analyzer was asked for, but not provided.

Manufacturer Narrative

Samples from the affected patients were not available, so no further investigation was possible.From the information provided, a general reagent issue can most likely be excluded.Additional information required for the investigation was requested, but not provided.Product labeling instructs the customer that samples should not be taken from patients receiving therapy with high biotin doses (> 5 mg/day) at least until 8 hours following the last biotin administration.The ft4 assay is unaffected by biotin levels up to 20 ng/ml.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 6921487
• MDR Text Key: 89939830
• Report Number: 1823260-2017-02206
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• 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: 140865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• 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
• Patient Age: 48 YR