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

Catalog Number 10444834

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens is in process of issuing an urgent field safety notice to notify all affected customers and updating existing software to resolve the issue.

Event Description

Siemens internally found that a testpak can be tested on the instrument regardless of the status of calibration and/or quality control if it is within the 48 hour window of lot expiry.A message is displayed next to the testpak lot number on screen alerting the customer that the testpak will expire within 48 hours.This message overwrites any other flags or messages that should be displayed when running a sample during the last 48 hours of use life.Siemens has not received any external complaint for the issue.There was no report of injury due to this issue.

Manufacturer Narrative

Siemens healthcare is currently developing software updates to address this issue.Additional data: siemens issued an urgent field safety notice (poc 16-019.A.Us) to notify all the affected customers in june 2016.

• Brand Name: STRATUS CS STAT FLUOROMETRIC ANALYZER
• 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; 62 flanders-bartley rd.; flanders NJ 07836
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5725827
• MDR Text Key: 47417595
• Report Number: 1217157-2016-00065
• Device Sequence Number: 1
• Product Code: JHX
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1217157-06-17-2016-001-C
• Patient Sequence Number: 1