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 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The customer has provided instrument log and sensor files for investigation.The customer has replaced the measurement cartridge and has been reviewing sodium results to confirm proper operation of the instrument.Investigation is ongoing.The cause of this event is unknown.

Event Description

The customer reported a discrepant low sodium result on a neonatal patient sample when compared to retesting of the same sample on a laboratory instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Has confirmed an issue with rapidpoint 500 systems measurement cartridges (with lactate).This issue has the potential to affect the sodium (na+) sensor, as well as cause a question result ¿-----?¿ error flag for multiple electrolytes on patient samples and quality control.When the na+ sensor is affected, na+ slope calibration errors (d3) will be seen in the recall events log during cartridge initialization, resulting in low na+ values.The maximum sodium bias on internal testing and reported by customers comparing results to other direct method analyzers was <10 mm.To date, the impact to na+ results has been observed in less than 1% of the rapidpoint 500 systems measurement cartridges (with lactate).The question result ¿-----?¿ error flag has been observed on electrolytes.This may occur at any time over the life of the cartridge.Based on the investigation, these issues are due to an electronic noise that is observed on rapidpoint 500 systems measurement cartridges (with lactate).Measurement cartridges without lactate are not affected.Siemens has released a notification "potential for low na+ values and question result error flags" to inform customers of the issue and provide workaround options.Crr# 3002637618-11-01-2023-0004.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY
• 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: 18144835
• MDR Text Key: 328982995
• Report Number: 3002637618-2023-00097
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 300263761811012023-0004
• Patient Sequence Number: 1