MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 BLOOD GAS SYSTEM; RP 500

Catalog Number 10696855

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

The customer reported discrepant results on two patients on the rp 500 s/n (b)(4) when compared to another rp 500 s/n unknown.Patient id # (b)(6) discrepant (b)(4), no results for ph.Patient id # (b)(6) discrepant (b)(4).There was no report of injury due to this event.

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Siemens has received the log files from the customer for investigation.The customer is operational.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation of the instrument log files provided by the customer.From the investigation it can be concluded that the instrument and the po2 sensor in the measurement cartridge appeared to be reporting the sample results as they were presented based on the sensors' slope and calibration stability.The rp500 results from the suspect patient samples appear valid.The instrument and cartridge performed as intended and the system is currently operational.There were no systemic po2 sensor related errors throughout the in-use life of the cartridge.A definite root-cause behind the alleged discordant low po2 results could not be determined.However, the low po2 result seems to be a sample related outcome as the redraw of the same patient (separate sample) tested 1 hour later which resulted in a higher po2 result (86.2 mmhg).

• Brand Name: RAPIDPOINT 500 BLOOD GAS SYSTEM
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 13002691
• MDR Text Key: 285922418
• Report Number: 3002637618-2021-00071
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10696855
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• 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