MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK NOVUS; AUTOMATED URINALYSIS SYSTEM

Catalog Number 10697937

Device Problem Low Test Results (2458)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

Customer is operational after troubleshooting.The discrepant result occurred as a result of operator error and use of a bent pipettor needle and overflowing stub.

Event Description

The customer obtained a falsely depressed blood result on their novus instrument when compared to a sediment result obtained on atellica uas.

• Brand Name: CLINITEK NOVUS
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; 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 ; 2 edgewater drive; edgewater, MA 02062
• MDR Report Key: 16638182
• MDR Text Key: 312286819
• Report Number: 3002637618-2023-00016
• Device Sequence Number: 1
• Product Code: KQO
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697937
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1