MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number 10484765

Device Problem Non Reproducible Results (4029)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested any remaining reagent to be sent back for investigation.The customer has requested possible causes for false negative leucocytes which have been provided.The cause of this event is unknown.

Event Description

The customer reported a false negative leukocyte result on the clinitek advantus when compared to the microscopic sediment and a non-siemens chemistry analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: investigational testing was performed on returned lot #004075 (exp 10/31/2021) using three technical operations owned clinitek advantus instruments (s/n (b)(6)).Testing was completed using a wbc negative solution (lot # jgf020321 exp 2/3/22) and a wbc positive 42 cells/ul solution (piwi-00464-msh lot # 0063-05 exp 6/3/21).Four results were obtained per instrument with both the wbc positive and wbc negative solutions.Results: no false negative results were reported.Based on the data collected, the customer report of false negative wbc performance from n-multistix sg-l lot #004075, as reported in gsms pm00264070 was not observed.The cause of this event is unknown.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11273150
• MDR Text Key: 231171761
• Report Number: 3002637618-2021-00005
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10484765
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1