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	09/30/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer alleged two false negative red blood cell (rbc) results on the novus while using two different lots of the novus cassettes.Comparison testing was performed on both their laboratory analyzer and uas800 (sediment test) which yielded positive results.There is no report of injury due to this event.
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 both impacted lots.As part of the investigation, the batch record as well as documentation on issues were reviewed by analyzing the novus line logbook during the dates of production.Additionally, the returned cassettes were tested using in-house instruments with a positive control.During the investigation, a review of all the novus cassettes manufactured for the impacted lots showed no records in their logbooks of a potential cause for a false negative red blood cell result.Based on the data collected, the customer¿s report of false negative red blood cells from both lots were 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 ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 20416155
• Report Number: 3002637618-2024-00098
• Device Sequence Number: 8209604
• 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): 02/05/2025

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: 10/01/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/05/2025
• 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