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

Model Number	10492730
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer states that both patients have the same last name and confirms that blood was drawn and collected from the intended, correct patient.Customer states that he deleted the sample with the incorrect acc# under patient history and invalidated the sample.He created a new order/acc# under intended correct patient which has been edited in the blood gas instrument under recall patient results.The customer states the issue was due to user error, the issue has been resolved and the instrument is operational and wants to close the investigation.
Event or Problem Description
The customer states that an order was created under the wrong patient which delivered blood gas results into the wrong patient's chart in lis.Customer states that both patients have the same last name and confirms that blood was drawn and collected from the intended, correct patient.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 10591
• MDR Report Key: 10756320
• Report Number: 3002637618-2020-00059
• Device Sequence Number: 17015714
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1