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

Catalog Number 10309478

Device Problem Patient Data Problem (3197)

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

Event Date 10/21/2014

Event Type  malfunction  

Event Description

Customer reported that instrument displayed erroneous patient sample id when they scanned the label on a tube.Customer also reported that patient sample id was missing 1 digit and sometimes it was replaced by another number or a letter and then randomly.There was no report of injury due to this event.

Manufacturer Narrative

Siemens customer service engineer (cse) indicated that internal barcode reader had been replaced by the in-house service technician.Cse also indicated that there have been no occurrences of a digit changing to another since replacing the barcode reader.

• Brand Name: CLINITEK ATLAS
• Type of Device: CT ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SPARTON MEDICAL; 22740 lunn road; cleveland OH 44149
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4342906
• MDR Text Key: 5202924
• Report Number: 1217157-2014-00194
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/24/2014

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: Medical Technologist
• Device Catalogue Number: 10309478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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