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 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested further information and instrument files for further investigation.The cause of this event is unknown.

Event Description

Customer reported that their (b)(6) sn instrument gave a discrepant thb result when compared to another analyzer.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation.Instrument files were reviewed.Absence of any drifts in glucose and thb sensors slope, flagged question result, or any related errors for glucose and thb sensors suggests the reported sensors were stable and performing normally as expected.Co-oximetry optical subsystem responsible for the measurement of thb appeared stable.No co-ox interference was detected.According to the customer, there was one day delay between sample collection and its analysis.A prolonged delay in sample collection and analysis can impact glucose and thb levels due to glucose and hemoglobin degradation over time which may have attributed to producing discrepant low results.Definitive root-cause for the sample discrepant low glucose and thb results is undetermined.

• 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; suffolk, sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 16948187
• MDR Text Key: 315410285
• Report Number: 3002637618-2023-00031
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/10/2023

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: 05/12/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male