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

Catalog Number 10492730

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the controls were in the expected ranges before and after the samples were run.Also, the customer believes the discrepancy is due to sample integrity and not the instrument malfunctioning because, in the past, samples that have been drawn from a-lines have been drawn without properly flushing the line first and proper technique is not always followed.There has been no other questionable results.The data files have been received.Siemens has requested that the customer return the measurement cartridge for investigation.

Event Description

The customer reported discrepant sodium results on two rp 500 instruments.There was no report of injury due to this event.

Manufacturer Narrative

Siemens reviewed the data provided by the customer for both rp 500 instruments.Rp500 sn (b)(4) na+ was stable with no errors or system errors around the time of the suspect result.On july 19th on rp500 sn (b)(4) the na sensor was impacted by a large disturbance associated with a quaternary ammonium compound such as benzylkonium.This caused fairly persistent na+ calibration errors lasting until july 20th, when the suspect sample was run.Per the rp500 operators manual these substances are known interferences to the rp500 na+ sensor and should be avoided.The customer did not question the result provided by rp500 sn (b)(4).Rp500 sn (b)(4) was not impacted by interference over use life and performed as expected.There were no sensor or system errors on either system just prior or after the suspect samples were run.On rp500 sn (b)(4), the sensor output is consistent with the result provided.The complaint mentions the sample may have had unspecified integrity issues; based upon the data provided the observations are consistent with this scenario.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7739596
• MDR Text Key: 115780436
• Report Number: 3002637618-2018-00089
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (y/n): N
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1