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 09/29/2023

Event Type  malfunction  

Event Description

The customer is alleging receiving discrepant low sodium results on siemens rp500 device with sno.42733 as compared to a non-siemens device.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has requested more information and instrument data files for investigation.Customer did not provide requested information.Siemens is unable to conduct an investigation.The cause of this event is unknown.

Manufacturer Narrative

Siemens completed the investigation.The complaint did not involve patient samples.There is no evidence that the device is not performing as intended.There is no allegation of any harm or adverse events and no patient results or treatments were affected.There is no actual death or injury and it could not lead to death or injury if the issue were to reoccur.The cause of the event is unknown.

• 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: 17942583
• MDR Text Key: 326403536
• Report Number: 3002637618-2023-00085
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup
• Report Date: 11/03/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/03/2023
• 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