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 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they received a discrepant pco2 result on one patient compared to retesting of the same sample on another rp500 instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation.Based on co-ox quality checks, performance with aqc, lack of any calibration drift or related diagnostic errors during the time of event, the co-oximetry optical subsystem responsible for the measurement of thb appeared stable with constant temperature and functioning as expected.No co-ox interference was detected through the escalation date and while the sample in-question was measured which suggests the thb value reported for escalated sample appear valid.Siemens has due diligence to determine what has been done to resolve/troubleshoot the customer¿s issue and if the instrument is currently operational at the customer site, however the customer has not responded.Absence of any drifts in slope of pco2 sensor, any related errors, question results, or abnormal measurements during the time when the reported sample was run, indicates that pco2 sensor was stable and performing normally as expected.No product problem identified.Note optical thb measurement is dependent on the quality of the sample, and specifically the red blood cell concentration as presented in the slide cell.Pre-analytics such as presence of partial clot, light exposure, insufficient mixing, sample inhomogeneity, may play a part in the observed difference between the results of reported and comparative rp500/500e systems.For an accurate measurement of thb in whole blood, it is known that thorough mixing and rotating of the red blood cells immediately before analysis is required.

• 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: 18639563
• MDR Text Key: 334525307
• Report Number: 3002637618-2024-00006
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/11/2024

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: 01/25/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 04/11/2024
• 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?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1