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

Model Number TSH

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of a possible biotin interference for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii (ft4 ii), elecsys t3 (t3) and elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 602 module.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results, medwatch with patient identifier (b)(6) for information on the t3 results and medwatch with patient identifier (b)(6) for information on the anti-tshr results.The patient has multiple sclerosis and has been taking higher doses of biotin (3 x 100 mg per day) for the past 6 months.The patient takes biotin each day at 8:00 a.M., 3:00 p.M.And 11:00 p.M.The patient sample in question was drawn at 8:30 a.M.On (b)(6) 2018.The patient didn't remember if he had taken biotin at 8:00 a.M.Or not.The customer performed a procedure on the patient sample to remove the biotin from the sample and repeated the sample.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).The patient sample could not be provided for investigation.Product labeling states that the tsh assay is unaffected by biotin levels up to 25 ng/ml.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.Since the sample could not be provided, the biotin interference could not be investigated.From the data provided, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8325419
• MDR Text Key: 135716926
• Report Number: 1823260-2019-00543
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2019

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 Model Number: TSH
• Device Catalogue Number: 11731459122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/11/2019
• 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
• Patient Age: 60 YR