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

Catalog Number 10453571

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and that controls have been run and are passing.The cause of the event is unknown.Service went on site and the issue was resolved by replacing the testpak and the system is operational.

Event Description

The customer reported discrepant elevated troponin results on the stratus cs.There was no report of injury due to this event.

• 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.; 62 flanders-bartly rd.; flanders NJ 07836
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6745077
• MDR Text Key: 81278628
• Report Number: 3002637618-2017-00118
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10453571
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR