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

Catalog Number 10484765

Device Problem False Negative Result (1225)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the return of remaining lot of reagent in use at the time of the event for investigation.Investigation will commence once materials have been received.The cause of this event is unknown.

Event Description

The customer reported that they received a false negative leukocyte result compared to retesting of the same sample using a flow cytometry analyzer and another chemistry analyzer.The customer stated that the discrepant result led to a delay in diagnosis a uti and therefore treatment of the patient.

Manufacturer Narrative

Siemens has completed the investigation.Testing was performed on returned reagent using three in-house clinitek advantus instruments, and analysis was completed using a 42 cell/l wbc solution (positive level for leukocyte internal testing) which should give between a small and moderate result.The customer report of a false negative result was not reproduced.No product problem identified.The cause of this event is unknown.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• 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: 18489203
• MDR Text Key: 332994917
• Report Number: 3002637618-2024-00113
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K063276
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10484765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1