MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS; CT ATLAS

Catalog Number 10309477

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2013

Event Type  Other  

Event Description

Customer reported that instrument displayed same barcode number on two separate tubes that had different bar codes.There was no report of injury due to this event.

Manufacturer Narrative

Customer indicated that they verified on a different analyzer that the two bar codes were different and on a second attempt instrument read the bar codes correctly.Siemens field service engineer has been dispatched to further investigate this event.

Manufacturer Narrative

Customer had field service engineer (fse) visit onsite.System is an atlas with rack sample handler.Fse determined issue with instrument was racks were not moving correctly causing the same to to idee to be read twice, but advancing in time to asparate from the second tube.Fse cleaned and adjusted the track, replaced the barcode reader and adjusted the tube detector.Instrument was then tested and problem could not be duplicated.

• Brand Name: CLINITEK ATLAS
• Type of Device: CT ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SPARTON MEDICAL; 22740 lunn rd; cleveland OH 44149
• Manufacturer Contact: steven andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3601612
• MDR Text Key: 4090759
• Report Number: 1217157-2013-00261
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K932674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2013

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 Catalogue Number: 10309477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 01/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1