MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK NOVUS

Model Number	10697937
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested further information and troubleshooting from the customer to conduct a more indepth investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported that their clinitek novus instrument gave a false negative leukocyte result compared to retesting the same paitent sample using a visual read multistix 10sg urine strip.The customer also reported the apperance of this paitent sample was notably cloudy.There was no report of injury as a result of this event.
Additional Manufacturer Narrative
The customer indicated event occurred due to user error.Per the ifu, turbid samples should not be tested.No additional investigation can be performed.

• Brand Name: CLINITEK NOVUS
• Common Device Name: CLINITEK NOVUS
• 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: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 15901292
• Report Number: 3002637618-2022-00070
• Device Sequence Number: 14727450
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: 00630414981147
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 10697937
• Device Catalogue Number: 10697937
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/06/2023
• 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