MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379677

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2015

Event Type  No Answer Provided  

Event Description

Customer reported that 3 barcodes misread by the barcode scanner.Customer also reported that they rescanned them with no error.There was no report of injury due to this event.

Manufacturer Narrative

Customer confirmed that no patient results were reported to physicians.The event is in process of investigation.

Manufacturer Narrative

Siemens investigated 3 patient/sample id barcodes sent by customer.Barcodes were scanned using barcode reader, the barcodes were identified as: 1 x code 39 without check digit.2 x interleaved 2 of 5 without check digit.Barcodes were scanned using status+ connect system, all 3 barcodes read correctly when scanned flat.When they applied to a curved sample pot, intermittent mis-scans were reported.Customer has been provided with following information: clinical laboratory standards institute (clsi) recommends using code 128 barcodes (which include a check digit) for patient demographics.In addition, it is recommended to apply the barcodes with the bars perpendicular to the axis of the container.If unable to switch to a different symbology, then recommendation is to add a check digit to their interleaved 2 of 5 barcodes, if possible.Customer did not have any further question/issue.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4546666
• MDR Text Key: 5518096
• Report Number: 1217157-2015-00023
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K032563
• 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,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10379677
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Patient Sequence Number: 1