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	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer complained of discrepant high results for 1 patient sample tested for elecsys tsh on a cobas e 801 module.The patient was tested on the e801 module and the tsh result was 5.11 uiu/ml and was reported outside of the laboratory.The result was questioned by the doctor as the patient is taking l-thyroxine and repeat testing by another method was requested.On (b)(6) 2018, the sample was sent to an external laboratory using an unknown method and the tsh result was < 0.01 miu/ml.This result was what the doctor expected for this patient.There was no allegation that an adverse event occurred.The 801 module serial number was (b)(4).
Additional Manufacturer Narrative
Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.

• 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: 7808776
• Report Number: 1823260-2018-02829
• Device Sequence Number: 1573362
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 4015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 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
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement 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
• Concomitant Medical Products and Therapy/Usage Dates: L-THYROXINE
• Patient Age: 58 YR