MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained about the results for 1 patient tested on multiple assays on the elecsys e170 modular analytics immunoassay analyzer.The patient was tested for elecsys ft4 ii assay (ft4 ii), elecsys tsh assay (tsh), elecsys t4 assay (t4), elecsys t-uptake assay (t-uptake), elecsys fsh assay (fsh), elecsys t3 (t3), elecsys ft3 iii (ft3 iii), elecsys estradiol iii assay (estradiol iii), elecsys progesterone iii (progesterone iii), elecsys pth (1-84) pth 1-84 and elecsys ferritin (ferritin).The pth 1-84 assay is not released for distribution in the united states nor is it similar to a device released for distribution in the united states.The results were reported outside of the laboratory where the physician did not believe the results.The patient is being treated with 100 mg of biotin per day for multiple sclerosis.The customer is wondering if the biotin treatment is interfering with the patient's test results.Product labeling states "samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration." the customer repeated the patient sample after treating it with a streptavidin coated bead treatment.The procedure used by the customer is unknown.The ft4 ii, tsh, t4, t-uptake, t3, ft3 iii, estradiol iii and ferritin results were discrepant when compared to the results initially released from the laboratory.Refer to medwatches with the following patient identifiers for the affected assays: (b)(6).Refer to the attached data for the patient results.There was no allegation that an adverse event occurred.The e170 analyzer serial number was (b)(4).The discrepant results generated during the customer's experiment were consistent with patients being treated with high biotin dosages.As no sample material was left, an investigation of the sample material could not be completed.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 7273740
• MDR Text Key: 100452506
• Report Number: 1823260-2018-00462
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• 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
• Date Manufacturer Received: 01/30/2018
• 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: 66 YR