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

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing. The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable thyroid results from a cobas 8000 e 801 module compared a wako accuraseed and an architect. Data that is a reportable malfunction for elecsys tsh assay, elecsys ft3 iii, elecsys ft4 iii assay, and elecsys ft4 ii assay for 1 patient was provided. This medwatch will cover tsh. For information ft3iii, ft4 iii, and ft4 ii refer to the medwatch with patient identifier's (b)(6) respectively. There was no allegation of an adverse event. The serial number for the cobas e801 used by the customer is (b)(4). The serial number for the cobas e801 used at the investigation site is (b)(4). The tsh reagent lot used on this instrument is 365417 with an expiration date of feb-2020. The ft4 ii reagent lot used on this instrument is 341695 with an expiration date of sep-2019. The ft4 iii reagent lot used on this instrument is 380330 with an expiration date of dec-2019. The ft3 iii reagent lot used on this instrument is 348359 with an expiration date of oct-2019.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8758206
• MDR Text Key: 150140606
• Report Number: 1823260-2019-02431
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage