MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number	10636672
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2018
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.Siemens has requested that the reagent and sample be sent back for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported a false negative leukocyte result on the clinitek advantus using multistix 10 sg when compared to a non-siemens reference lab and the microscopic examination of the sediment.There was no report of injury do to this event.
Additional Manufacturer Narrative
Updated contact office - name/address.The customer received several false negative leukocyte results.The customer noted that in the samples that gave a false negative result, gave positive protein results.The customer returned reagent for investigation.Tech ops was unable to reproduce the customer complaint using the returned reagent.The customer states at least 70% of his patients have a sg higher than 1.015.Per customer bulletin 26181 "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." the customer has requested conference calls to go over this issue.Marketing and customer service may continue to work with the customer to review leukocyte test specifications and limitations.No further dcu action is required.There is no indication that the product is not operating as specified.

• Brand Name: CLINITEK ADVANTUS
• Common Device Name: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7848425
• Report Number: 3002637618-2018-00104
• Device Sequence Number: 11146759
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/17/2019

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
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1