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

Catalog Number 10453571

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens issued an urgent field safety notice (# poc 16-019.A.Ous) in june 2016 informing customers of a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours.As stated in the "actions to be taken by the customer" section of the urgent field safety notice: do not use testpaks that are due to expire within 48 hours.The customer acknowledged that they received the urgent field safety notice prior to this event.The customer reported that the testpak lot has been discarded.

Event Description

The customer reported that they calibrated a ctni testpack that was about to expire and got an "*****above assay range" error message when a sample was run.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: 6141235
• MDR Text Key: 61603266
• Report Number: 3002637618-2016-00159
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10453571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2525-2016
• Patient Sequence Number: 1