MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Model Number	10636672
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has received a replacement analyzer and is operational.The customer has confirmed that there are no injuries or damages to any property.
Event or Problem Description
The customer reported that their clinitek advantus sn (b)(4) had urine spilled accidently inside the analyzer and the instrument started smoking near the printer.The operator immediately unplugged the unit.The customer has confirmed that there are no injuries or damages to any property.

• Brand Name: CLINITEK ADVANTUS
• Common Device Name: ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 12636583
• Report Number: 3002637618-2021-00061
• Device Sequence Number: 1240268
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063276
• 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: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 10636672
• Device Catalogue Number: 10636672
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1