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

Catalog Number 10697306

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

The customer stated that they suspect the medication that the patient is taking (memantin) could interfere with the rp 500 results.The data logs have been provided for investigation.The customer does not believe there is any issue with the rp 500 and states they are operational.The cause of this event has not been confirmed.

Event Description

The customer reported discrepant sodium results for one patient on the rp 500 compared to results from a non-siemens lab analyzer.The customer suspects that the drug the patient is taking (memantin) could be an interfering substance.There was no report of injury due to this event.

Manufacturer Narrative

Siemens reviewed the trace logs provided by the customer.The customer stated that this patient was taking the drug memantine.Suspect elevated na+ patient results may have been impacted by the drug memantine which is a known interferent to the rp 500 sensor.Memantine will increase sodium recovery depending on the concentration of memantine which is consistent with the complaint information provided.The na+ sensor over use life appears typical and very stable.There were no calibration failures or major systemic events from (b)(6) - (b)(6) 2018 when the suspect samples were run.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7974749
• MDR Text Key: 126094953
• Report Number: 3002637618-2018-00121
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1