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	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).(b)(4).
Event or Problem Description
The customer provided data for a total of 8 samples from 8 different patients tested for multiple thyroid assays on the cobas 8000 e 801 module.Of these samples, five had erroneous results for the elecsys tsh assay.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.Refer to the attachment for all patient data.All highlighted values are erroneous.The samples were initially tested on the customer's e 801 analyzer.The samples were provided for investigation, where they were tested on a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.The samples were also tested on a centaur analyzer.In addition, the samples were treated with polyethylene glycol (peg) and tested on a roche elecsys analyzer.No adverse events were alleged to have occurred with the patients.The serial number of the e 801 analyzer used at the customer site was asked for, but not provided.The serial number of the e 801 analyzer used for investigation was (b)(6).Tsh reagent lot number 331814, with an expiration date of 31-aug-2019 was used on this analyzer.The serial number of the e 602 analyzer used for investigation was (b)(6).Tsh reagent lot number 328081, with an expiration date of 31-dec-2018 was used on this analyzer.The serial number of the e 411 analyzer used for investigation was (b)(6).Tsh reagent lot number 328081, with an expiration date of 31-dec-2018 was used on this analyzer.The differences in results from assays from different vendors are related to the differences in the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the standardization methodology used.The normal reference ranges used by different assay vendors can equally be different.This relates to the population used and the calculation mode.A discrepancy in relation to the normal reference range is observed in some patients.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: 7850272
• Report Number: 1823260-2018-03008
• Device Sequence Number: 13844763
• 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): 09/06/2018

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: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1