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

Model Number	10492730
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested additional information for investigation multiple times and the customer has declined to provide the information.This includes a stated event report, paz and r1 files and patient printouts.The customer stated there were multiple reagent errors.Without the log files, an investigation will not be able to be performed.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant low pco2 results run on an rp 500 instrument when compared to another rp 500 instrument.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9983156
• Report Number: 3002637618-2020-00019
• Device Sequence Number: 2078115
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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 Model Number: 10492730
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2020
• Initial Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1