MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS

Catalog Number	10494134
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and that none of the discrepant results were reported to the physician.All results were caught during sample examination.Cleaning and technique were reviewed with the customer.The sg well cleaning is done daily per the sop.Samples are mixed well before being poured off into urine tubes.Qc is run daily and all results are within range.Siemens has asked the customer to provide the novus 10 reagent for investigation.The cause of this event is unknown.
Event or Problem Description
The customer reported false negative urine leukocyte results on four patients on the clinitek novus when compared to the microscopic examination of the urine sediment.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens tech.Operations has completed the investigation on novus 10 cassettes returned by the customer, of the same lot (k549079) used for testing.The batch record for k549079 was inspected as well as documentation regarding issues in the novus line log book.There were no issues recorded during the manufacturing process.Based on the reviewed data and novus results from testing performed on the returned cassette, the customer report of false negative wbc results from novus 10 cassette lot k549079 was not observed.

• Brand Name: CLINITEK NOVUS
• Common Device Name: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9322730
• Report Number: 3002637618-2019-00120
• Device Sequence Number: 10914319
• Product Code: KQO
• UDI-Device Identifier: 00630414981130
• UDI-Public: 00630414981130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 12/20/2019

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
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1