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

Catalog Number 10379675

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens field service engineer (fse) troubleshot the issue over the phone.Fse provided instructions to the customer on how to disable the manual entry of patient id numbers and requested that the customer confirm that the barcode scanner connector was secure in the connect platform.Fse then attempted to run the unit without the manual entry of patient id's and the issue didn't return.Siemens field service engineer advised customer to use the barcode scanner and not to enter any information manually.The issue has been resolved.Customer satisfied with the explanation.Instrument is operational.

Event Description

Customer reported that erroneous patient id was reported when they scanned barcodes containing patient id number.Customer indicated that patient sticker was scanned and the result never crossed over to the patients chart, because the 4th digit in the barcode was reported as a 5 when it should have read 6.Customer also indicated that the sample was then rerun and the patient id was entered manually.Customer confirmed that patient treatment was not delayed or altered.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 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: 6326084
• MDR Text Key: 67581869
• Report Number: 3002637618-2017-00020
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2017

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: 02/07/2017
• Initial Date FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1