MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+

Catalog Number	10379675
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested that the instrument as well as any batteries and/or power supply in use at the time of the event be returned for further investigation.Investigation will commence once the instrument has been received.The cause of this event is unknown.
Event or Problem Description
The customer reported their clinitek status+ device was smoking.The device lost connectivity to the network and started smoking.There was no visible fire.The customer removed the batteries and disconnected the device from the base.The customer tried powering on the device, but it was unsuccessful.There is no report of harm due to this event.
Additional Manufacturer Narrative
The customer returned their instrument for investigation however, the power supply and batteries were not provided.The investigation concluded that the smoking the customer saw was due to a failure of the d16 diode which fails when it is exposed to overvoltage.The customer stated that when the incident occurred, they immediately removed the batteries and disconnected the instrument from the clinitek status connect system.Per the connect system operator¿s guide, ¿you cannot operate the instrument on battery power when using the connector.¿ the cause of this event was due to user error.

• Brand Name: CLINITEK STATUS+
• Common Device Name: CLINITEK STATUS+
• 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: 23682365
• Report Number: 3002637618-2025-00080
• Device Sequence Number: 13223127
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: (01)00630414574639
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091216
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/09/2026
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown