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

Catalog Number 10379675

Device Problems Computer Operating System Problem (2898); Programming Issue (3014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2015

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed that no results were misreported due to this incident.Customer has been requested to send results print out from instrument showing wrong barcode.Customer declined to send results printout.Customer has been provided with new barcode reader and requested to send affected barcode reader back to siemens for investigation.Customer has received the new barcode reader and they have had no issues with its operation.The cause for the issue is unknown.

Event Description

Customer stated that the barcode scanner was scanning but was changing the last two digits of the scanned barcode.Customer stated their middleware (rawls) flagged the result before it hit the lis and customer had to go into the result and changed the last two digits to the correct ones and resent to lis.There was no report of injury due to this event.

Manufacturer Narrative

Siemens investigated the event and it was noted that a fair amount of difficulty occurred in trying to successfully scan the barcode selected.Closer inspection of the scanner window revealed an unknown substance not dissimilar to a dried splash mark on the surface.Once the detritus was removed from the emitter detector window the barcode scanner functioned as expected without error.

• 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: 4882944
• MDR Text Key: 23121867
• Report Number: 1217157-2015-00088
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

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
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1