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

Catalog Number 10444834

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

Customer indicated that the original sample (plasma) is no longer available.This is the sample that was taken on (b)(6) which gave the 0.73 ng/ml positive result.Customer wanted to know if a bubble in the sample could cause a false positive result? siemens customer product support (cps) team cps stated that while a bubble in a sample could possibly cause an error to flag there is nothing to indicate that a bubble could lead to a false result.Siemens field service engineer performed post test, system check and auto alignments to check for gross adjustments.He also ran precision and controls.Biorad control lot 29830 trop test pak: level #1 0.41, 0.41, 0.41, 0.40., sd=0.005 cv=1.350 level #3 5.28, 5.39, 5., 08, 5.22, sd=0.130 cv=2.48 all systems were passed with no issues and precision on controls were within parameters.The cause for the discordant troponin results is unknown.

Event Description

Customer reported discordant troponin results on stratus cs analyzer.There was no report of injury due to the event.

Manufacturer Narrative

This complaint is not confirmed.Numerous factors can contribute to a discrepant ctni result, including the instrument, reagent testpak, and operators.The cause of the discrepancy in results cannot be determined based up on the information that customer provided.The original sample was not available for investigation.System check was run and passed (b)(6).Qc is passing and customer ran a successful precision study.Technical bulletin "effects of sample integrity on accuracy and precision" has been reviewed with the customer.As per the ctni ifu samples should be inverted 8 to 10 times immediately after collection for complete anticoagulant mixing.Cellular debris is one possible cause of elevated test results.Instrument is operational.There is no evidence that a siemens product is not meeting specifications.

• 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: 5647825
• MDR Text Key: 45160956
• Report Number: 1217157-2016-00055
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984067
• 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: 06/20/2016

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: 10444834
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR