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
Event or Problem Description
The customer reported that their clinitek novus instrument gave a false negative leukocyte result compared to retesting the same patient sample using a visual read multistix 10sg urine strip.There was no report of injury as a result of this event.
Additional Manufacturer Narrative
Siemens has requested further information and troubleshooting from the customer to conduct a more in depth investigation.The cause of this event is unknown.
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: 15899522
• Report Number: 3002637618-2022-00071
• Device Sequence Number: 20114422
• 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: 12/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown