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

Catalog Number 10379675

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Customer stated there is nothing wrong with the instrument.She is convinced that techs were doing something wrong, she feels that the way the barcode scanned that one time was an issue with the system that creates the labels, and/or rals.Customer indicated that they have seen nothing similar before or since.Siemens had issued a customer bulletin, "barcode usage with siemens' point of care devices" in (b)(6) 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.Instrument is performing as intended.

Event Description

Customer indicated that operator was performing a urine pregnancy test on the instrument, he scanned the label, he double checked the scanned csn # on the machine with the label, and it was correct.When the results printed out, he noticed that 2 digits were missing.The "33" in the middle of the csn # (b)(4) were missing.Operator repeated the test with the same patient label, and this time, the correct csn # appeared on the printed results.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 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: 5933288
• MDR Text Key: 54158282
• Report Number: 1217157-2016-00099
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1