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

Catalog Number 10444834

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens investigated customer returned test paks and they were determined to be meeting specifications.After reviewing the message log, it has been determined that sample quality issues generated an abnormal aspiration.Sample integrity may adversely affect the accuracy of test results.The aspirations affected are indicative of poor sample quality.Both runs of the original sample showed abnormal aspirations however the first run was most impacted.Customer will be provided with technical bulletin "the effects of sample integrity on accuracy and precision" to educate them about proper sampling.Cellular debris fibrin clots and/or particulate matter are some factors that adversely affect sample integrity.The cause for the discordant troponin results was determined to be sampling issue.

Event Description

Customer reported falsely elevated troponin result on the analyzer.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: 5261097
• MDR Text Key: 32537619
• Report Number: 1217157-2015-00177
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10444834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1