MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379675

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens investigated the issue and planning to upgrade the software to resolve the issue.

Event Description

Siemens internally found following: in the case that an operator transmits all data stored in the instrument and selects the "send all" button, the software allows for the instrument to stop displaying the busy signal while still transferring data.The customer is then able to run a test while the instrument is still transferring data, although the instrument might be slow to respond.Depending on the amount of data being transferred and the speed at which it is transferred, there is a delay in the times at which the reagent is read.This issue affects clinitek status + software versions 2.6 and 2.61 only.Siemens has not received any external complaint related to this issue.

Manufacturer Narrative

Siemens issued an urgent field safety notice 34002 (clinitek status+ connect systems possible delay in read times for urinalysis results) to notify customer about the issue on january 25, 2016.As per ufsn, following actions to be taken by the customer: "please perform the following steps: enable "authorized operators" on all instruments that are running v2.60/2.4.0.0 or v2.61/2.4.1.0 to ensure the "send all" feature is not inadvertently used by your institution's regular operators.Refer to "setting up the authorized operators" in the system configuration section of your clinitek status+ operator's guide for specific steps on how to set this up.Instruct the individuals with administrative rights to the "instrument settings" and the "send all" function on your clinitek status+ connect system that this function should not be used." customer may continue to run instrument and report patient results, as long as the "send all" function is not being utilized.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5304344
• MDR Text Key: 34362200
• Report Number: 1217157-2015-00184
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• 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: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1