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 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested more information and instrument files for further investigation.Investigation will commence once the requested data has been received.The cause of this event is unknown.

Event Description

The customer reported that they received a discrepant total hemoglobin result when compared to retesting of a new sample on their laboratory instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has shown due diligence in attempting to obtain additional required information for investigation from the customer.However, to date, there have not been any additional updates to these requests and no other information has been provided.Without the requested information or instrument log files, the investigation could not proceed.Without an investigation, the root cause cannot be determined.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, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18763174
• MDR Text Key: 336080446
• Report Number: 3002637618-2024-00012
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1