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

Catalog Number	ASKU
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).(b)(6) patient data.
Event or Problem Description
The customer received questionable thyroid results for one patient sample from cobas 8000 cobas e 602 module serial number (b)(4) when compared to the results from an (b)(4) architect.The results from the cobas e602 did not correlate with patient symptom and an interference was suspected.Refer to the medwatch for all patient data.This medwatch is for elecsys tsh assay.Refer to the following medwatch with patient identifier for the other assays involved: elecsys t3= (b)(6).Elecsys t4 assay= (b)(6).Elecsys ft3= (b)(6).Elecsys ft4 assay= (b)(6).The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.
Additional Manufacturer Narrative
The customer returned 3 sample vials from the patient for investigation.The differences between the values generated with the cobas 8000 cobas e 602 and the abbott analyzer are within normal reference range of the respective assays.

• 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: 7965344
• Report Number: 1823260-2018-03668
• Device Sequence Number: 18877600
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR