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 07/23/2023

Event Type  malfunction  

Event Description

The customer reported that they received discrepant low sodium results on several patients compared to retesting of new samples on a non-siemens device (dimension).Customer has reported that this system has been having sodium interference flags intermittently since (b)(6) 2023.There is no report of injury due to this event.

Manufacturer Narrative

Customer has provided instrument log files for further investigation.Investigation underway.The cause of this event is unknown.

Manufacturer Narrative

Investigation was completed.The instrument log files of the reported system and two comparative systems were reviewed and analyzed.The summary log determines that one na_cal threshold dead error was detected by system about 5 hours before first reported sample measurement followed by 8 sodium sensor interferent detected events, 14 d2 excessive drifts, and 3 d3 slope errors for the na+ sensor.Consequently, the na+ sensor was disabled several times by the system to maintain normal functioning.The errors indicate the sensor was exposed to sodium sensor interferent (unknown source) several times which, as stated in the system manual, makes the sodium sensor unstable during the time when reported samples were measured.According to the information provided, the rp500e instrument is operating normally at the customer site.

• 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, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17548637
• MDR Text Key: 321404081
• Report Number: 3002637618-2023-00062
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2023

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: 11416755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/12/2023; 09/12/2023
• Supplement Dates FDA Received: 09/19/2023; 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1