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

Model Number TSH

Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for 46 patient samples tested for ft4 iii assay on a cobas 8000 e 801 module compared to the beckman dxl. Of the data provided, there were 7 patient samples with discrepant ft4 iii and elecsys tsh assay results, 21 patient samples with discrepant ft4 iii results, and 9 patient samples with discrepant tsh results. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results. The e 801 module serial number was (b)(4).

• 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: 8887465
• MDR Text Key: 154169483
• Report Number: 1823260-2019-02961
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 01/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TSH
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2019
• 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