MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB ANALYTICAL WORKCELL

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse changed the dimension software "schedule tests" configuration from "optimize time/hm first" to "optimize time to results" to force the aspiration of a waiting sample.A siemens headquarter support center (hsc) specialist reviewed the instrument data.The sample in question ((b)(6)) was locked in place and aliquoted on one analyzer then reloaded back to the input/output module and placed in an output rack at 9:37.There was no error associated with this sample on the automation system.There was a re-run ordered at 10:52 but it was routed to another analyzer.Siemens is investigating this issue.

Event Description

Delay in receiving patient results was observed on a streamlab core unit instrument.The customer provided an example of a patient sample ((b)(6)) which was pipetted at 9:36 and at 10:53, and the results were received at 11:08 from a dimension instrument.There are no reports of patient intervention or adverse events due the delay.

Manufacturer Narrative

The initial mdr 1226181-2016-00482 was filed on october 31, 2016.Additional information (12/14/2016): the customer is operational.There has been no impact on patients due to the delay reported.The issue was resolved with a configuration change on the dimension instrument software.The cause of the delay reported was due to a configuration issue.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: STREAMLAB ANALYTICAL WORKCELL
• Type of Device: STREAMLAB ANALYTICAL WORKCELL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): INPECO S.P. A; registration #: 3005509212; via givoletto 15; val della torre, 10040 ; IT
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6067943
• MDR Text Key: 58851480
• Report Number: 1226181-2016-00482
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2017

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: Health Professional
• Device Model Number: STREAMLAB ANALYTICAL WORKCELL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1