MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE ANALYZER

Catalog Number 10282969

Device Problems Display Difficult to Read (1181); Patient Data Problem (3197)

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

Event Date 02/03/2015

Event Type  No Answer Provided  

Event Description

Customer reported that erroneous patient id was assigned to a sample.Customer reported that barcode reader misread patient barcodes and uploaded result for patient to another patient id profile in emr.Customer also reported that barcode for patient b ((b)(4)) was scanned and uploaded as id for patient a ((b)(4)).Customer stated that they couldn't be sure if incorrect barcode was scanned at the time of test but stated that they have noticed issue occurring with operator ids and inputting incorrect symbols into id when barcode was scanned.There was no report of injury due to this event.

Manufacturer Narrative

Customer indicated that both patients were asked to have blood drawn again to re-test sample.Customer stated that error was noticed when profile for patient b was pulled up and no results displayed for the day.Customer confirmed that results were close enough that no harm was done to patients.Customer had been contacted to see if they could be able to locate the barcodes and be able to determine whether the issue was due to scanning the incorrect barcode? customer indicated that issue had not occurred again and she did not consider the occurrence to be an instrument issue.Customer indicated that they believed that wrong barcode was scanned and considered issue to be operator related.Customer indicated that they do not require further follow up and assistance.

• Brand Name: DCA VANTAGE ANALYZER
• Type of Device: DCA
• 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: 4562466
• MDR Text Key: 5476757
• Report Number: 1217157-2015-00028
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071466
• 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
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10282969
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1