MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS+ USA; CT STATUS

Catalog Number 10379675

Device Problems Device Operates Differently Than Expected (2913); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

Customers barcode reader on instrument has scanned four patient id's incorrectly.There was no report of injury due to this event.

Manufacturer Narrative

Cause for barcode reader changing id's is unknown.

Manufacturer Narrative

Siemens product service support (pss) team met with the customer and scanned barcodes that were causing issues and they were unable to recreate any of the errors that had been occurring with scanning barcodes.Pss stated the scanned several new barcode labels as well as barcode labels that had been scanned in with error and were unable to reproduce the error.Pss tried to scan barcodes on both flat and round surfaces and every barcode was scanned properly.Siemens team spoke with the operators of the new instrument that was sent to them and contrary to what was reported, they have not had any issues with the barcodes on the new system.All issues were occurring on the initial system which has been exchanged for the customer.Initial unit was not tested by the sales representative so the issue was unable to be verified.Instrument is not available for further testing.No further action is required.Unit received as exchange is operational.

• Brand Name: CLINITEK STATUS+ USA
• Type of Device: CT STATUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; manufacturing, ltd.; northern road; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4006521
• MDR Text Key: 4689839
• Report Number: 1217157-2014-00114
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2014

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: Other Health Care Professional
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1