MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 405 BLOOD GAS ANALYZER; RP 405

Catalog Number 10320055

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Also the customer stated that the operator resolved the issue remotely with siemens service support by changing out the cartridges.The customer is operational.The requested data files have been received for investigation.

Event Description

The customer reported discrepant total hemoglobin results between the rp 405 and a non-siemens hematology instrument.There was no report of injury due to this event.

Manufacturer Narrative

Siemens reviewed the data files provided.The available data suggests that the co-ox optical components were functionally correctly.No error messages were flagged with either of the rp405 measurements.Review of the event logs for the mcart installed at the time of the escalation indicates no thb slope or drifts errors immediately prior or after the discordant sample.The aqc results were within the expected ranges and the co-ox optical performance was within specifications.Root-cause for the low thb result compared to repeat analyses is unknown.

• Brand Name: RAPIDPOINT 405 BLOOD GAS ANALYZER
• Type of Device: RP 405
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7355343
• MDR Text Key: 103277908
• Report Number: 3002637618-2018-00031
• Device Sequence Number: 0
• Product Code: GKR
• Combination Product (y/n): N
• PMA/PMN Number: K020616
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10320055
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR