MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 11731459122

Device Problem Low Test Results (2458)

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

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable low elecsys tsh assay result for one patient sample from a cobas 6000 e 601 module.The serial number was requested but was not provided.The tsh result was 0.047 uu/ml and was questioned as it did not match the patient's clinical condition.The patient underwent a thyroid ultrasound that was normal and a scintigraphy that was normal.Information regarding if the erroneous result was reported outside the laboratory or if the patient was adversely affected was requested but it was unknown.An interference was suspected as the patient was taking biotin (100 mg 3 times daily) for multiple sclerosis.

Manufacturer Narrative

Sample from the patient was submitted for investigation.An interfering factor to streptavidin in the sample was excluded.A very high biotin concentration was detected in the sample which was considerably higher than the allowable concentration specified in product labeling for the assay.This high level of biotin most likely caused the event.There was no product problem found.For diagnostic purposes, results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 6185739
• MDR Text Key: 62858313
• Report Number: 1823260-2016-01993
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K961491
• 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,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11731459122
• Device Lot Number: 16605401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• 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
• Treatment: BIOTIN