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 10/21/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens has received customer returned sample for investigation.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.There was no report of injury due to this event.

Manufacturer Narrative

Two samples collected from the patient on (b)(6) 2015 were sent to the siemens site for investigation, along with 6 testpaks from lot 235173002, the lot that was used when the 0.23 ng/ml result was obtained.Investigation conclusion: internal testing confirmed that the discrepant patient samples returned from the customer were falsely elevated due to heterophile antibody interference.The initial result obtained on the stratus cs was 0.23 ng/ml and then, after sample treatment with a heterophilic antibody blocking reagent, a mean result of 0.03 ng/ml was obtained on the stratus cs.This verified that the elevated result was due to heterophilic antibody interference (nonspecific binding) with the stratus cs ctni assay.

• 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: 5289183
• MDR Text Key: 33272073
• Report Number: 1217157-2015-00182
• 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,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1