MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. POCCELERATOR DATA MANAGEMENT SYSTEM

Catalog Number	10732871
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has added a check that all patient ids must be 8 digits in length and that if the patient demographics are not known to poccelerator when processing the test results, poccelerator will not forward to the lis.These actions were added to minimize the potential of this occurring again.The cause of this event was due to operator error.No device problem found.
Event or Problem Description
The customer has reported multiple occurrences of a device operator scanning their operator id badge for the patient id at time of testing, which has resulted in the test results posting to the incorrect patient's chart.The customer stated that the error was easily identifiable.There is no report of injury due to this event.

• Brand Name: POCCELERATOR DATA MANAGEMENT SYSTEM
• Common Device Name: POCCELERATOR
• 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: 23980716
• Report Number: 3002637618-2026-00002
• Device Sequence Number: 14593888
• Product Code: JQP
• UDI-Device Identifier: 00630414208275
• UDI-Public: (01)00630414208275
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 01/06/2026

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: 10732871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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