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 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

The customer provided the instrument log files for investigation.Siemens has completed the investigation and based on the instrument log review, the root cause for the suspected discrepant low sodium results were due to an unstable na+ sensor.The na+ sensor was exposed to a quaternary ammonium compound (qac) such as benzalkonium or chlorhexidine, noted as 'sodium sensor interferent detected' on several dates on and around the date of the discrepant results.Per the siemens customer facing documentation, these substances are known interferents to the na+ sensor by destabilizing the sensor and impacting results, therefore should be avoided.These products should be eliminated for use.The customer has replaced the measurement cartridge and is operational.

Event Description

The customer reported that their rp500e instrument gave several discrepant low sodium results compared to repeat testing of a different sample on a non-siemens 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 ; 62 flanders-bartly rd.; flanders, NJ 07836
• MDR Report Key: 13620048
• MDR Text Key: 296580549
• Report Number: 3002637618-2022-00015
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

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: 02/03/2022
• Initial Date FDA Received: 02/28/2022
• 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
• Patient Age: 9 MO
• Patient Sex: Male