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 08/25/2022

Event Type  malfunction  

Event Description

The customer reported that their clinitek novus instrument gave a false negative leukocyte result compred to retesting of the same sample on a sediment analyzer and another chemistry analyzer.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has requested further information and troubleshooting from the customer to perform further investigation.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigaiton.Instrument logs provided only contained the instrument status messages.Without the patient results or decodes available a definitive root cause cannot be determined.Samples that contain intact/not lysed leukocytes have the potential to produce a negative result on the leukocyte esterase pad.It is likely that the leukocytes in the sample that were visible on microscopy were not sufficiently lysed to generate a positive result on the leukocyte esterase pad.Microscopy/sediment analysis detects visible and intact leukocytes, which is different from chemical urinalysis which detects leukocyte esterase.Leukocyte esterase is only present in samples where the leukocytes have lysed and released the analyte into the surrounding specimen.While leukocyte esterase is correlated with the presence of leukocytes in sediment analysis, they are not perfectly predictable of one another.Based off available information the novus appears to be function as intended.

• 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; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 15352403
• MDR Text Key: 305582704
• Report Number: 3002637618-2022-00056
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: 00630414981147
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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: 12/14/2022

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
• 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
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1