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

Catalog Number 10697306

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

The customer has provided instrument files for further investigation.An initial view of the files provided show "sodium sensor interferent detected" messages.Investigation ongoing to determine if this was the cause of the event.

Event Description

Customer alleges discrepant low sodium result when compared to retesting of a different sample on the same analyzer and another rp500 analyzer.There is no report of injury due to this event.

Manufacturer Narrative

Based on the review and analysis of the provided data for the instrument log with the measurement cartridge installed, aqc expected recovery, raw signal responses, reagent response curves, and calibration history; the root cause for the low na+ result recoveries for the escalated patient samples in question were due to an unstable na+ sensor.The na+ sensor was exposed to quaternary ammonium compounds (qac).The customer confirmed the use of clinell wipes.Per the customer bulletin 2020-12 (cust-00271-edg): ¿exterior disinfecting cleaners for the rapidpoint® 405/500/500e systems¿ and the rapidpoint 500 operator¿s guide, any cleaning agent that contains benzalkonium or other quaternary ammonium compounds as an ingredient should not be used as an exterior disinfectant for the rapidpoint 405/500/500e systems and sampling devices used for blood gas analysis.These substances are known interferents to the na+ sensor and can destabilize the sensor, causing calibration issues, and significantly impacting results; therefore, should be avoided.The source containing qac should be identified and eliminated.The rp500 instrument is currently operational at the customer site.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18741200
• MDR Text Key: 336880416
• Report Number: 3002637618-2024-00011
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122539
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1