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

Catalog Number	10492730
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Siemens service reviewed the system event log for error messages and "sodium interference" messages were received on the day before and the day of this event.The requested data logs have been received for investigation.The measurement cartridge has been discarded.The customer stated that they installed a new cartridge, the aqc were in the expected ranges and they are operational.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant high sodium results on the rp 500.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens reviewed the data provided by the customer.The na+ sensor was severely impacted by a quartenary ammonium compound such as benzylkonium.A message was displayed in the event log indicating sodium interference was detected by the analyzer.Per the rp500 operators manual, these substances are known interferences to the rp500 na sensor and should be avoided.The customer is taking a cleaner containing benzyl ammonium chloride out of use.The system is operational.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7770167
• Report Number: 3002637618-2018-00095
• Device Sequence Number: 13724423
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1