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

Catalog Number 10453531

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer had been requested to return reagents (testpaks and dilpaks) for further investigation.Customer indicated that they did not have any reagents left to return.The cause for the discordant troponin result is unknown.

Event Description

Customer reported falsely elevated troponin result on the analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Customer indicated that they did not have testpaks or dilpaks for return.Customer confirmed that analyzer is operational.

Manufacturer Narrative

Initial mdr 121715-2015-00121 and mdr 1217157-2015-00121 fu1 were filed in error.The complaint was related to (b)(6) result and not troponin.There was no report of injury to the patient or operator due to this event.This event is not reportable to fda as per 21 cfr 803 and justification for not filing will be recorded in complaint files.

• 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: 5028064
• MDR Text Key: 24787583
• Report Number: 1217157-2015-00121
• 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
• Report Date: 10/09/2015

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: Not provided
• Initial Date FDA Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 YR