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

Catalog Number 10697937

Device Problem False Negative Result (1225)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

The customer obtained a false negative leukocyte result on their novus analyzer when compared to retesting of the same sample on a sediment analyzer.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has requested more information for further investigation.The cause of this event is unknown.

Manufacturer Narrative

Customer stated that product was unable to be returned for further investigation.Additionally, system logs could not be provided.Without the returned product and logs, the investigation cannot proceed and therefore the root cause cannot be determined.Proper maintenance and technique were reviewed with the customer and no issues were identified.Siemens reviewed the certificate of analysis for the lot in question and the product met and passed all specifications upon manufacturing release.The cause of this event is unknown.

• Brand Name: CLINITEK NOVUS
• Type of Device: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 16901865
• MDR Text Key: 314898575
• Report Number: 3002637618-2023-00026
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: GG
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697937
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1