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	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer stated that they received erroneous results for one patient sample tested with the elecsys tsh assay and the elecsys ft4 ii assay on an unknown roche elecsys analyzer.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The patient sample was initially tested on the customer's roche analyzer.The sample was repeated on a centaur analyzer.The sample was also provided for investigation, where it was tested on a cobas 8000 e 602 module (e602).The model and serial number of the customer's roche elecsys analyzer were asked for, but not provided.The serial number of the e602 analyzer used for investigation is (b)(4).Tsh reagent lot number 328081, with an expiration date of december 2018 was used on this analyzer.Calibration and controls were ok on the e602 analyzer used for investigation.The investigation did not identify a product problem.  the cause of the event could not be determined.  different assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.

• 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: 7906802
• Report Number: 1823260-2018-03290
• Device Sequence Number: 19253231
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 4015630899661
• 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): 09/25/2018

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: 11731459122
• Device Lot Number: 328081
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1