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

Catalog Number	10697937
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that two patients produced false negative red blood cell (rbc) results on the novus while using the novus cassettes 450 lot.Comparison testing was performed on the uas800 (sediment test) which yielded a positive result.There is no report of injury due to this event.
Additional Manufacturer Narrative
Initial investigation led to a discussion on having a service engineer to be dispatched and inspect the instrument.Customer reported that internal and external quality controls are all passing.Reagent is being requested back for further investigation.The cause of this event is unknown.
Additional Manufacturer Narrative
The cassettes were returned, and review of the patient's false negative red blood cell results were analyzed.An investigation was conducted on the returned cassettes from the impacted lot.As part of the investigation, the production records for the instrument and reagent were reviewed which showed no indication of a potential systemic cause for a false negative red blood cell result.Additionally, the returned cassettes were tested using in-house instruments with a positive control.Based on the data collected, the customer¿s report of false negative red blood cells from the lot was not observed.The customer's reported issue was not reproduced.The cause of the event is unknown.No product problem detected.

• 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, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 20584871
• Report Number: 3002637618-2024-00118
• Device Sequence Number: 15631857
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: (01)00630414981147
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140717
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 10697937
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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