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

Catalog Number 11416755

Device Problem Low Test Results (2458)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The customer provided instrument log files for further investigation.Based on the instrument log review, the root cause for the suspected discrepant low sodium result when compared to repeated na+ results generated on the lab instrument was due to an unstable na+ sensor within the measurement cartridge.The na+ sensor was exposed to a quaternary ammonium compound (qac) such as benzalkonium or chlorhexidine, noted as a "sodium sensor interferent detected'' error.The customer stated that they use cleaning wipes that contain a qac.The customer has replaced the measurement cartridge and has been instructed to cease using disinfectants containing qacs.The customer is operational.

Event Description

The customer reported a discrepant low sodium result from their rp500e instrument compared to repeat testing of the same sample on a non-siemens lab instrument.There is no report of injury due to this event.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• 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, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 13860089
• MDR Text Key: 287672150
• Report Number: 3002637618-2022-00020
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 11416755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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