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

Catalog Number 10379675

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has been advised to change the orientation of the barcode on container.Customer was explained that changing orientation to vertical may improve scans.Siemens had issued a customer bulletin, "barcode usage with siemens' point of care devices" in june 2015.As per bulletin, "siemens point of care devices support a range of barcode formats, so please refer to your devices operator's manual to determine which specific barcode formats your device supports." it also advises customer to use clinical & laboratory standards institute® (clsi) standards as it provides specifications for labeling and the use of linear bar codes on specimen tubes.Customer bulletin was provided to the customer.

Event Description

Customer stated that instrument barcode reader was not scanning patient id barcodes correctly.Customer indicated that unit was connected to lis via middleware and ids were not scanned correctly.Customer also indicated that numbers were transcribed incorrectly from barcode reader to instrument after being scanned.Customer indicated that there were three occurrences of this event.Customer confirmed that 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 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: 5905044
• MDR Text Key: 54049200
• Report Number: 1217157-2016-00089
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1