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

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problem Mechanical Problem (1384)

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

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc instructed the customer to pause and cancel pause on the dimesnion vista.The customer also reset radio frequency identification (rfid) tag reader for sampling gate.The customer then started sending samples to the dimension vista instrument, and samples resulted as expected.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse stated that the tube properly went to the output properly as the streamlab caught an issue with the rfid on a specific tube.The cse checked the rfid system, and instrument gate and track.The cause of the discordant results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The operator of a streamlab core unit stated that sampling error was obtained on one patient sample.Discordant results for multiple methods were obtained on initial run.The discordant results were not reported to the physician(s).The sample was repeated on the same instrument and an alternate dimension vista instrument, and both results matched.It is unknown if the corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant results.

• 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 avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5139606
• MDR Text Key: 27902687
• Report Number: 1226181-2015-00574
• 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
• Report Date: 09/11/2015

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: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1