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

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)

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

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens regional support center (rsc) specialist evaluated data from the streamlab.One print-out showed the information from when a search was run for a rack id and the other showed the information from when sample ids in that same rack were searched.The information did not match.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse reloaded software 4.3.0 and ran four sample tubes through the streamlab core unit.The cse verified the samples were in the correct location in the output rack.The cse then stated that the lab put tubes on to be sealed.The cse obtained a rack printout after all the tubes were sealed, before removing the rack from the streamlab input/output (i/o).The cse verified the physical location of the tubes matched the printout of the rack.Siemens is investigating the issue.

Event Description

An analyzer connected to a streamlab automation system was scheduled to aspirate sample id (b)(6) for a repeat test, but a different sample id of (b)(6) was associated with the sample when it was routed to the streamlab priority output rack.The operator noticed that the sample id did not match and did not report the results.The operator manually loaded the sample onto the analyzer for repeat testing and the repeat results matched the results obtained when the sample was run from the automation track.There are no known reports of patient intervention or adverse health consequences due to the sample id mismatch.

Manufacturer Narrative

The initial mdr 1226181-2016-00422 was filed on august 30, 2016.Additional information received (09/12/2016): a siemens headquarters support center (hsc) reviewed the data supplied.Hsc did not find a mix up of samples.Hsc noted that the samples were separated by many other samples in the queue.Sample (b)(6) was loaded onto track in carrier (b)(4) and was scheduled to run in instrument 2 but the instrument queue was full.The sample took two track laps, waiting for an opening on an instrument.A queue became available on instrument 1 and the sample was routed to instrument 1.When released from instrument 1, the sample was returned to rack (b)(4) lane 04 position d05.Sample (b)(6) was loaded onto the track in carrier (b)(4) and scheduled to run on instrument 1.The sample was routed to instrument 1.When released from instrument 1, the sample was returned to rack (b)(4) lane 04 position d02.There was no issues found by hsc.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 (torino), 10040 ; IT 10040
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 5915655
• MDR Text Key: 53553478
• Report Number: 1226181-2016-00422
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

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: No Information
• Device Model Number: STREAMLAB ANALYTICAL WORKCELL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1