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

Catalog Number 10697306

Device Problems Use of Device Problem (1670); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens requested the data files for investigation and only limited data is available.The paz files have been received and no other data is available.The r1 and cx files are not available.The cause for this event is unknown.

Event Description

The customer reported discrepant results for total hemoglobin and sodium when run on two rp 500s.The customer does not know which results were accepted as true.There was no report of injury due to this event.

Manufacturer Narrative

Siemens reviewed the available data files provided by the customer.The sodium sensors and thb assays are performing as intended.For thb: the observed difference in thb results is due to the inconsistency in the application of correlation coefficients.A specific set of correlation coefficients for thb is being utilized on one rp 500 system (s/n (b)(4)) however this has not been applied to the other rp 500 system (s/n (b)(4)).The customer has since applied the same thb correlation coefficient factors to the second system so both rp 500 instruments are configured identically.Na+ may have been influenced by two events that occurred immediately prior to the suspect specimen.The two events were a d39 obstruction detected on the second to the last sample measured prior to the suspect specimen, which was then followed by a sample which prompted a retrocal which was measured 4 minutes before the suspect specimen.The retrocal response was most likely driven by an exposure to a quaternary ammonium compound (like benzalkonium).Across the use-life of the measurement cartridge there was evidence of a similar exposure, all of small magnitude.As per the rp 500 operator's manual, benzalkonium is a known interferent to the na sensor and these substances should be avoided.The root cause for the discordant elevated na+ is not fully known.

• 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: 7621089
• MDR Text Key: 112434343
• Report Number: 3002637618-2018-00070
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K113216
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1