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

Catalog Number 10379675

Device Problem Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

Event Type  No Answer Provided  

Event Description

Customer reported that barcode reader scanned in patient id and scanned an id that was different than the id on barcode.Customer stated that barcode was for patient id# (b)(6) and id that scanned in was (b)(6).Customer explained that an error occurred with this patient id when it transmitted to qcm3(middleware) and did not allow her to save the results and because the id had been used earlier for a sample that had a thyroid test performed.There was no report of injury due to this event.

Manufacturer Narrative

Customer has been asked if the same barcode could be obtained when scanned again.Customer indicated that they scanned barcode and the correct id appeared for id (b)(6).The same barcode was repeatedly scanned and the correct id appeared on instrument.Customer confirmed that this issue did not cause a mix of patient ids and results as lis software marked test with an error due to id being used previously.Customer indicated that they will continue testing and will call back if issue occurs again.The cause for the issue is unknown.

Manufacturer Narrative

Customer called back and stated that they were unable to verify used barcode symbology but the issue is resolved.Customer indicated that they could not explain what caused the issue but stated that they have had no more issues with this problem occurring.

• 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: 4521027
• MDR Text Key: 5360438
• Report Number: 1217157-2015-00018
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1