MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW STRATUS CS

Catalog Number 10444834

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

This event pertains only to qc and no patients were impacted based on the data provided by the customer.During internal investigations, it was determined that this issue could potentially impact patient results.

Event Description

The customer reported that the cardiac low level troponin (ctni) control is out of range high.There is no report of injury due to this event.

Manufacturer Narrative

The lot that showed elevated qc results, lot # 237170002, expired on december 16, 2017.Internal testing has been conducted on 22 lots since this lot was manufactured and the issue has not recurred.Additional testing indicates that patient results are not impacted.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW; glasgow business community; newark DE 19702
• MDR Report Key: 7365414
• MDR Text Key: 103793798
• Report Number: 3002637618-2018-00038
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (y/n): N
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10444834
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1