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 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse adjusted the radio frequency identification tag reader at sampling gate for the dimension vista instrument.The cse adjusted the diverter to increase the speed of the pallets.The cse then monitored signal strength and released the instrument to the customer.The cause of wrong sampling of patient samples 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 the sample tubes from the input/ output of the streamlab to the dimension vista instrument were not sampled correctly.The instrument flagged "possible wrong result" and "no sample" after two sample tubes were scanned.The operator stated that possibly wrong tests were run on a patient sample.The operator was aware of the error and ensured that the correct results were sent to the laboratory information system for each sample.The operator repeated the samples and compared results.There are no reports of patient intervention or adverse health consequences due to the wrong sampling of patient samples.

• 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: 5246510
• MDR Text Key: 32028152
• Report Number: 1226181-2015-00675
• 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
• Report Date: 11/03/2015

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: 11/03/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1