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 04/13/2024

Event Type  malfunction  

Manufacturer Narrative

A field service engineer performed a check on the analyzer and found the system to be operational.The customer provided instrument log files to be investigated.A preliminary review showed a sodium interferent was detected on the day of the discrepant result.Investigation is currently ongoing to determine if this was the cause of the event.Cause of event is unknown.

Event Description

Customer alleges discrepant sodium (na+) results when compared to retesting of a different sample on their laboratory analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens completed the investigation.An examination of the sodium sensor calibration trace log, system events log, and automatic quality control results from the customer instrument shows that the sodium sensor was experiencing a period of instability during time of analysis of the escalated samples.The events log shows ¿sodium sensor interferent detected¿ events occurred frequently throughout measurement cartridge use life this is indicative of sensor instability resulting from exposure to a sodium sensor interferent such as quaternary ammonium compounds (qac).Customer bulletins and the rapidpoint 500 operator¿s guide recommends not to use any skin disinfecting products and/or exterior disinfectants that contain qac as they are known interferents to the rp500/500e na+ sensor by potentially impacting the sensor and its¿ performance and should be avoided.The source containing qac should be identified and eliminated.The root cause was due to user error.

• 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: 19159496
• MDR Text Key: 341278005
• Report Number: 3002637618-2024-00042
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• 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
• Patient Age: 23 YR
• Patient Sex: Male