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

Model Number 10697937

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 307180693
• Report Number: 3002637618-2022-00070
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: 00630414981147
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10697937
• Device Catalogue Number: 10697937
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1