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

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens is in process of investigating the issue.The cause for the discordant troponin results is unknown.

Event Description

Customer reported falsely elevated troponin result on the analyzer.Customer wanted to know how viscosity affects troponin i result on the stratus cs.There was no report of injury due to this event.

Manufacturer Narrative

Customer stated that the sample was clotted.Customer will not be returning reagent for investigation and provided log files did not include information for the date of the event.The presence of clots in a sample might have adversely affected the results.Siemens representative provided technical bulletin "the effects of sample integrity on accuracy and precision" to customer to educate them regarding the sample handling.

• 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: 5445932
• MDR Text Key: 38527364
• Report Number: 1217157-2016-00017
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1