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

Catalog Number 07028091190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned results from 1 patient sample tested for elecsys tsh (tsh), elecsys ft4 ii (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas e801 module.The sample was submitted for investigation and discrepant tsh results were identified between the customer's e801 module, the centaur method, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer.It is not known if incorrect results were reported outside of the laboratory.Refer to attached data for the patient results.The patient sample was also treated and underwent polyethylene glycol (peg) testing.Refer to attached data for these results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The e602 serial number was 1286-07.The e411 analyzer serial number was 1368-02.The tsh reagent lot number used with the e602 module was 294897 with an expiration date of 31-aug-2018.The tsh reagent lot number used with the e411 analyzer was 291617 with an expiration date of 31-jul-2018.Calibration and qc at the investigation site were acceptable.From the data provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.The investigation was unable to find a definitive root cause.

• 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: 7609261
• MDR Text Key: 112157474
• Report Number: 1823260-2018-01943
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• 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: N
• Patient Sequence Number: 1