MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number 10484765

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the qc is consistently passing and the operator is using correct technique.Additionally, the operator is performing maintenance as described in the operator's guide.After review of the attached result receipts it was determined that all three samples reported higher levels of specific gravity ranging from 1.020 to 1.030.As described in the siemens customer bulletin dated 2011-09: "the cell membranes of leukocytes tend to lyse more readily in urines with lower specific gravity (hypotonic), but they remain intact for longer periods in urines with higher specific gravity (hypertonic).Since the reagent strip reacts with the leukocyte elastase (an esterase) contained within the cell, it is necessary for some of the cells to have lysed in order to be detected with the reagent strip.Therefore, urine samples with higher specific gravities tend to have fewer lysed cells, which would produce fewer positive reagent strip results.Microscopically, the intact leukocytes would still be visible." this may explain why the fse was able to reproduce the customer's observations.The complaint data provided demonstrates that instrumental and visual readings were consistent.

Event Description

The customer reported discrepant leukocyte results on three patients between the clinitek advantus and the microscopic readings.There was no report of injury due to this event.

Manufacturer Narrative

Contact office - manufacturing site, changed name and address to: (b)(4).

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: steven andberg ; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne,, MA 62080 ; PL 62080 ; 7812693655
• MDR Report Key: 6485183
• MDR Text Key: 72795739
• Report Number: 3002637618-2017-00067
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 10484765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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