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

Catalog Number 10444834

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Chest Pain (1776)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Customer reported discordant troponin results on the instrument.The patient was admitted to the cardiology emergency department because of chest pain and ws kept under observation for 24 hours according to the site's internal procedure.Customer indicted that no other symptoms related to heart diseae were reported.The patient's discharge was delayed by 2 hours due to the additional testing (after positive result).There was no report of injury due to this event.

Manufacturer Narrative

Siemens representative indicated that the message log could not be reviewed because the customer turned off the instrument and the sample was not available for evaluation so no further investigation into the issue could occur.As a precautionary measure, the siemens representative changed the syringes and the pressure, however the call did not indicate a failure with the system.The cause for the discordant troponin result is unknown.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC. - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19702
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3844830
• MDR Text Key: 4661253
• Report Number: 1217157-2014-00033
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• 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
• Patient Sequence Number: 1
• Patient Age: 42 YR