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

Catalog Number 10453531

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens current product support (cps) team investigated the issue.Investigation summary: ctni testpak lot 235151002 demonstrated acceptable performance when tested internally.When lot 235151002 was tested with bio-rad qc and cap samples, the lot performed as expected.This lot also had comparable performance to a second ctni testpak lot which was tested at the same time.Neither of the patient samples was returned, so the impact of the sample on the discrepant result could not be investigated.Based on the fact that there was a discrepancy between analyzers, a possible cause could have been antibody interference in the stratus cs assay that caused the stratus cs to provide an elevated result.

Event Description

Customer reported falsely elevated troponin result on the instrument.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 - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5177377
• MDR Text Key: 29238092
• Report Number: 1217157-2015-00149
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10453531
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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