MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS

Catalog Number	10494134
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens service went onsite.The customer had recalibrated the instrument once they saw the discrepant results between the novus and the microscopic examination.Service ran controls and reran the samples that had negative leukocytes on the novus and positive wbcs microscopically and then ran them on the customer's other novus.The leucocyte results now matched between the two novus' and the microscopic results.Service checked reagent card alignments and all optical adjustments and all were in specification.The instrument was calibrated again due to the optical checks and ran more patient samples.Service stated that recalibration resolved the issue and the system was fully functional on departure.The customer ran qcs at specified intervals and all were in the expected ranges.The customer stated that there were no false negative results reported.
Event or Problem Description
The customer reported false negative leukocytes on the clinitek novus (s/n (b)(4)) when compared to the same clinitek novus after being recalibrated, another clinitek novus (s/n unknown) and the microscopic examination of the sediment.There was no report of injury due to this event.

• Brand Name: CLINITEK NOVUS
• Common Device Name: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8343552
• Report Number: 3002637618-2019-00018
• Device Sequence Number: 1203598
• Product Code: KQO
• UDI-Device Identifier: 00630414981130
• UDI-Public: 00630414981130
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: 10494134
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1