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

Catalog Number	11731459122
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 1 patient sample tested for elecsys tsh assay (tsh) and elecsys ft4 ii assay (ft4 ii) on a cobas 6000 e 601 module.Based on the data provided, the tsh results are a reportable malfunction.The initial tsh result was 2.88 uiu/ml on the e601 module.The sample was repeated on the e601 module with a result of 2.88 uiu/ml.On (b)(6) 2018 the sample was repeated on the e601 module and the result was 2.86 uiu/ml.The customer sent an aliquot of the sample to an external laboratory using the beckman coulter method and the tsh result was 5.90 uiu/ml.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).The pinch tube was last replaced on (b)(6) 2018.Liquid flow cleaning was last performed on (b)(6) 2018.Rack adapters were not used for 13 mm sample tubes.
Additional Manufacturer Narrative
A sample was provided for investigation.The investigation determined an interfering factor was detected.In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.This interference is addressed in the product labeling.The investigation did not identify a product problem.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8050896
• Report Number: 1823260-2018-04143
• Device Sequence Number: 13905091
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 11731459122
• Device Lot Number: 32808101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR