MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number	10636672
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.The customer declined to send any materials for further investigation.Proper technique and maintenance were reviewed with the customer as well as possible causes of a falsely depressed leukocyte result.The customer had not lubricated the push bar as often as recommended and are operating at a slightly less than recommended temperature.Since they installed the new fixed platform and lubricated the push-bar rail, they have not had any further discrepancies.The instrument is operational.
Event or Problem Description
The customer reported discrepant leukocyte results on the clinitek advantus when compared to the microscopic examination of the urine sediment.There is no report of injury due to this event.

• Brand Name: CLINITEK ADVANTUS
• Common Device Name: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9215846
• Report Number: 3002637618-2019-00113
• Device Sequence Number: 16775273
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10636672
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR