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

Catalog Number 11731459122

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable results for two samples from the same patient tested with the elecsys tsh assay on a cobas 6000 e 601 module.The serial number of the analyzer was not provided.The first sample was tested (b)(6) 2016 with a tsh of 8.06 mu/l; the repeat result was 8.06 mu/l.The second sample was tested (b)(6) 2016 with a tsh of 3.04 mu/l; the repeat result was 3.04 mu/l.To the best of the customer's knowledge, the patient received no treatment between the two samples.The clinician did not agree with the difference in the results.There was no allegation of an adverse event.Patient samples were sent to the manufacturer for testing.

Manufacturer Narrative

The two patient samples were returned to the manufacturer for testing.The investigation reproduced the customer's results.Interference testing was performed.No interferences were found.No product problem was found.

Manufacturer Narrative

Calibration signals were ok.Control values were within specifications.A general reagent issue can most likely be excluded.Factors such as stress, changes in physical activities and circadian variations can cause variations in tsh values taken from samples from the same patient in a short period of time.

• 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: 6175351
• MDR Text Key: 62678571
• Report Number: 1823260-2016-01963
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11731459122
• Device Lot Number: 185522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• 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