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	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their clinitek novus instrument gave a false negative leukocyte result compred to retesting of the same sample on a sediment analyzer and another chemistry analyzer.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has requested further information and troubleshooting from the customer to perform further investigation.The cause of this event is unknown.
Additional Manufacturer Narrative
Siemens has completed the investigaiton.Instrument logs provided only contained the instrument status messages.Without the patient results or decodes available a definitive root cause cannot be determined.Samples that contain intact/not lysed leukocytes have the potential to produce a negative result on the leukocyte esterase pad.It is likely that the leukocytes in the sample that were visible on microscopy were not sufficiently lysed to generate a positive result on the leukocyte esterase pad.Microscopy/sediment analysis detects visible and intact leukocytes, which is different from chemical urinalysis which detects leukocyte esterase.Leukocyte esterase is only present in samples where the leukocytes have lysed and released the analyte into the surrounding specimen.While leukocyte esterase is correlated with the presence of leukocytes in sediment analysis, they are not perfectly predictable of one another.Based off available information the novus appears to be function as intended.

• Brand Name: CLINITEK NOVUS
• Common Device Name: 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, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 15352403
• Report Number: 3002637618-2022-00056
• Device Sequence Number: 14953102
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: 00630414981147
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• 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): 12/14/2022

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: 08/25/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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