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

Catalog Number	07028091190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer questioned thyroid results for 6 patient samples tested for elecsys ft3 iii (ft3 iii), elecsys tsh (tsh) and elecsys ft4 iii (ft4 iii) on a cobas e 801 module.The 6 patient samples were submitted for investigation where discrepant results were identified for ft3 iii, tsh and ft4 iii between the customer's e801 module, the centaur method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.It is not known if any incorrect results were reported outside of the laboratory.This medwatch will cover tsh.Refer to medwatch with (b)(6) for information on the ft4 iii erroneous results and medwatch with (b)(6) for information on the ft3 iii erroneous results.Refer to attached data titled "patient results" for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The patient samples were also treated and underwent polyethylene glycol (peg) testing.Refer to attached data titled "peg testing" for these results.The e602 module serial (b)(4).The e411 analyzer serial (b)(4).The e801 module serial number used at the investigation site was (b)(4).The tsh reagent lot number used with the e602 module was 311038 with an expiration date of 31-oct-2018.The tsh reagent lot number used with the e411 analyzer was 291617 with an expiration date of 31-jul-2018.The tsh reagent lot number used with the e801 module at the investigation site was 283556 with an expiration date of 28-feb-2019.There was not enough sample volume left to complete the investigation.Based on the data provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.The investigation was unable to find a definitive root cause.

• 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: 7719585
• Report Number: 1823260-2018-02463
• Device Sequence Number: 1329002
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 4015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/25/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1