MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500

Catalog Number 10697306

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  No Answer Provided  

Event Description

Customer reported falsely high sodium (na+) result on the instrument.There was no report of serious injury due to this event.

Manufacturer Narrative

Siemens personnel visited the site and observed the practice of placing samples in a bowl that had been wiped with a benzalkonium containing substance, thus contaminating samples with benzalkonium.The customer was reminded that this compound (benzalkonium) is a known interferent as listed in the rapidpoint 500 operator's manual.The customer was advised to stop this practice or use an alternate wipe product to avoid na+ contamination.The event has occured due to an operator error.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• 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: 4276636
• MDR Text Key: 5292950
• Report Number: 1217157-2014-00180
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10697306
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1