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

Catalog Number	07028091190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).(b)(4).
Event or Problem Description
The customer complained of questionable thyroid results for 2 patient samples tested on a cobas 8000 e 801 module and a cobas 8000 e 601 compared to a siemens centaur.From the data provided, a reportable malfunction was provided for elecsys tsh assay (tsh), elecsys t3 (t3), elecsys t4 assay (t4), and elecsys ft4 ii assay (ft4 ii).Medwatches related to this issue included patient identifiers (b)(6).Please refer to the attachment to this medwatch for patient data.The erroneous results were not released outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number was (b)(4).The cobas e601 serial number was requested but was not provided.The investigation is currently ongoing.
Additional Manufacturer Narrative
Further investigation determined the differences in tsh results were not caused by an interference.The observed differences in tsh results were due to the fact that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The customer provided samples for each patient for further investigation.The samples were tested on a system without a pre-wash (cobas e411), compared to systems with a pre-wash (cobas e601, cobas e801).Initial investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the reagent which affects the sample results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is documented in product labeling.Product labeling states "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.".

• 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: 7702337
• Report Number: 1823260-2018-02394
• Device Sequence Number: 731913
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 04015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup
• Report Date (Section B): 10/09/2018

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 Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 06/26/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/17/2018; 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR