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 11/20/2022

Event Type  malfunction  

Manufacturer Narrative

Clarifying information has been requested from the customer.The customer has provided instrument log files.Investigation is underway.The cause of this event is unknown.

Event Description

The customer received discrepant low potassium results compared to retesting of a different samples on a non-siemens lab instrument.There is no report of injury due to this event.

Manufacturer Narrative

After reviewing the system data logs, the rapidpoint instrument in question was found to be functioning as intended.There were no system or sensor related error events in and around the time of the escalated samples.The qc performance was found to be stable throughout the use life of the installed cartridge.For this patient, there were two extreme k+ recoveries on (b)(6).However, the rapidpoint and lab instrument potassium agreed for the samples analyzed within 10 minutes of each other.The cause of this event is unknown.

• 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: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 15995736
• MDR Text Key: 308079485
• Report Number: 3002637618-2022-00077
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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
• Date Manufacturer Received: 02/13/2023
• 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