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

Catalog Number	10492730
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Siemens has requested log files for investigation.The customer stated that the measurement cartridge has been replaced.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant total hemoglobin results on the rp 500 compared to a non-siemens lab analyzer.There is no report of injury due to this event.
Additional Manufacturer Narrative
The customer was not able to provide instrument logs or details on the instrument condition to determine the root cause of the thb result discrepancy.The customer notes that their other rp 500 instruments correlated well with rp 500 sn (b)(6) and their other non-siemens lab instruments correlated well with the non-siemens lab instrument in this complaint.The customer has stated that the discrepancy may be due to a difference in measuring methodology between the rp500 and the non-siemens lab instrument.Siemens sustaining engineering states that there is a well established bias between different methodologies for thb but there is not enough evidence to confirm this specific event.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7805074
• Report Number: 3002637618-2018-00103
• Device Sequence Number: 1573364
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR