MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number 10636672

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  malfunction  

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 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
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): KIMBALL ELECTRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne, 62080 ; PL 62080
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 9215846
• MDR Text Key: 164915883
• Report Number: 3002637618-2019-00113
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10636672
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 20 YR