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

Catalog Number	07028091190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
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, elecsys ft4 ii and elecsys ft3 iii on a cobas e 801 module.The patient sample was submitted for investigation where discrepant results were identified for tsh and ft3 iii between the customer's e801 module, the centaur method and an e801 module used at the investigation site.The initial results from the customer site were reported outside of the laboratory.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.Refer to attached data 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 e801 module serial number used at the investigation site was (b)(4).The tsh reagent lot number used with the e801 module at the investigation site was 331814 with an expiration date of aug-2019.
Additional Manufacturer Narrative
There was not enough sample remaining to complete the investigation.From the information provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case siemens, can generate different results.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 7961315
• Report Number: 1823260-2018-03644
• Device Sequence Number: 1682207
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 04015630939831
• 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,Followup
• Report Date (Section B): 11/07/2018

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: 09/25/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR