MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; RP 500E

Catalog Number	11416751
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation was completed.Based on the information provided, the root cause was due to operator error.It appears that the operator printed a label of a patient who was not an inpatient but registered in the hospital¿s system.The incorrect printed label was placed on a sample and scanned by the operator.The results transmitted to the lis system and were transferred to the wrong patient.It was discovered that both patients had similar ids that had 1 digit different.The rp500e is performing as intended.
Event or Problem Description
The customer reported that on (b)(6) 2025 @ 18:06 a barcode label was printed for a patient (id: (b)(6) who was registered in the hospital system but was not an inpatient.The label was placed on a sample for an inpatient (id: (b)(6).The issue was discovered by the physician as there were no results in the inpatient's chart because results were transferred to wrong patient.Account numbers: (b)(6) (not inpatient), (b)(6) (inpatient).There is no report of injury due to this event.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Common Device Name: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 22104012
• Report Number: 3002637618-2025-00039
• Device Sequence Number: 7023324
• Product Code: CHL
• UDI-Device Identifier: 00630414286143
• UDI-Public: (01)00630414286143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: 11416751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown