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	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results.Siemens has requested that the reagent be sent back for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported false negative leukocytes on the clinitek advantus using multistix 10 sg when compared to the microscopic examination of the sediment.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens tested the submitted reagent strips which showed no obvious visible damage or degredation.The bottle arrived tightly capped and containing the expected desiccant.Three test solutions were created to represent a negative, trace and small positive sample.The returned strips were tested with these solutions and the results were as expected.The false negative leukocyte results reported by the customer, when testing with multistix 10sg on the advantus could not be reproduced.
Additional Manufacturer Narrative
Tech ops has completed the second investigation.Using the returned reagent and patient sample, tech ops was able to reproduce the error of a false negative leukocyte result.Repeat testing microscopically gave results within the 5-15 cells/hpf range for a trace result.Sg data was also collected on the sample and the specific gravity reported as 1.020.Per customer bulletin: causes of leukocyte discrepancies between reagent strip and microscopic method: "it has been observed that higher urine specific gravity may sometimes cause decreased leukocyte test results.One factor involves specific leukocyte elastase inhibitors present in urine.These natural inhibitors reduce the activity of the elastase enzyme.Higher concentrations of these inhibitors would tend to be found in urines with higher specific gravities.This could thereby cause a decreased leukocyte result on the reagent strip.

• Brand Name: CLINITEK ADVANTUS
• Common Device Name: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7317210
• Report Number: 3002637618-2018-00027
• Device Sequence Number: 19196361
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/14/2018; 04/25/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/16/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1