MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS SYSTEM

Catalog Number 10697306

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

The customer reported that their instrument gave discrepant low total hemoglobin result compared to their laboratory instrument.There is no report of injury due to this event.

Manufacturer Narrative

The customer provided instrument files for investigation.Investigation is underway.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation.A review of the instrument files provided show that the instrument including the co-oximetry subunit was found to be performing as intended.There were no system or sensor specific errors in and around the time of the patient sample in question was measured.The aqc (automatic quality control) data for the thb (total hemoglobin) parameter was stable for the duration of measurements and within reportable range.Thb assays are known to be highly sensitive to sample collection and handling techniques.Preanalytical factors like hemolysis and insufficient mixing, time to sampling, etc.Are known causes for imprecise thb results.For the patient sample in question, the sensor raw responses were not provided; therefore, anomalous behavior could not be reviewed.The rp500 instrument is performing as intended and is currently operational at the customer¿s site.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500 BLOOD GAS SYSTEM
• Type of Device: RAPIDPOINT 500 BLOOD GAS SYSTEM
• 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: 18622411
• MDR Text Key: 335410703
• Report Number: 3002637618-2024-00005
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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
• Date Manufacturer Received: 02/26/2024
• 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?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1