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	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).(b)(4).
Event or Problem Description
The customer complained of a questionable elecsys tsh assay result and a questionable elecsys ft4 ii assay result for 1 patient sample tested on a cobas 8000 e 801 module compared to the results from an architect analyzer and a siemens centaur analyzer.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results.Please refer to the attachment for patient data.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was not provided.The cobas e801 serial number used at the investigation site was (b)(4).The tsh reagent lot number used at the investigation site was 283556 with an expiration date of feb-2019.The investigation is currently ongoing.
Additional Manufacturer Narrative
The customer's cobas e801 serial number was (b)(4).The investigation determined that a general reagent issue can most likely be excluded.The noticed discrepancies for tsh and ft4 ii between the cobas e801 results versus the competitor systems is likely explained by the fact that the 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.
Additional Manufacturer Narrative
Na.

• 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: 7785802
• Report Number: 1823260-2018-02730
• Device Sequence Number: 228517
• 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,Followup
• Report Date (Section B): 09/21/2018

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: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 07/30/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 08/23/2018; 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1