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
This event occurred in (b)(6).(b)(4).
Event or Problem Description
The customer stated that they received erroneous results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 ii assay an a cobas 6000 e 601 module.The erroneous results were reported outside of the laboratory and the physician requested an investigation of the sample.The sample was provided for investigation where it was tested for tsh, ft3, and ft4 ii on a cobas 8000 e 602 module on (b)(6) 2018.The sample was repeated on a centaur analyzer and an architect analyzer.This medwatch will apply to the tsh assay.Patient identifiers for information related to the remaining assays: (b)(6) = ft3, (b)(6) = ft4 ii.Refer to the attachment for all patient data.No adverse events were alleged to have occurred with the patient.The customer's e 601 analyzer serial number is (b)(4).The e 602 analyzer used for investigation is (b)(4).Tsh reagent lot number 328081, with an expiration date of december 2018 was used on this analyzer.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.All values, generated with all types of analyzers, are within the normal reference ranges of the respective assays.

• 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: 7918627
• Report Number: 1823260-2018-03337
• Device Sequence Number: 19316885
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• 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): 11/01/2018

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: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1