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

Catalog Number 10322347

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.The data files have been requested for investigation.The cause of the event is unknown.

Event Description

The customer reported discrepant elevated total hemoglobin results on the rp 405 when compared to a laboratory analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has reviewed the instrument data files.The co-ox diagnostic information indicates that the co-ox slide cell on the rp 405 was stable and consistent during this testing period.There was no indication of chronic co-ox related issues across the life of the mcart and thb recovery for aqc samples were within published ranges.Specific root-cause for the dissimilar thb results could not be determined.

• Brand Name: RAPIDPOINT 405 BLOOD GAS ANALYZER
• Type of Device: RP 405
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6898712
• MDR Text Key: 87738720
• Report Number: 3002637618-2017-00132
• Device Sequence Number: 0
• Product Code: GKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2017
• 2 Devices were Involved in the Event: 1 2

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: 10322347
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 10/31/2017
• 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: Unknown
• Patient Sequence Number: 1