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

Catalog Number	11731459122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer questioned results for 2 patients tested for elecsys tsh assay (tsh) and elecsys ft4 ii assay on a cobas 6000 e 601 module.The results were reported outside of the laboratory.The doctor is questioning the tsh results for both patients as they don't correspond to the progression of treatment.The ft4 ii results for one patient (patient 2) are discrepant.This medwatch will cover tsh.Refer to medwatch with (b)(6) for information on the ft4 ii results.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).
Additional Manufacturer Narrative
No sample could be provided for investigation.With the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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: 7952285
• Report Number: 1823260-2018-03525
• Device Sequence Number: 16469182
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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): 11/09/2018

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: 11731459122
• Device Lot Number: 29489700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 40