MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS

Catalog Number	10697937
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
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.Proper maintenance and technique were reviewed with the customer and no issues were found.Reagent is stored properly and no deterioration was seen on the test pads.A new novus was installed at the customer site and they are operational.The customer also stated that the original instrument is no longer at the customer site for further troubleshooting.A review of the lot of reagent used has not shown any similar complaints.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant blood results in urine between the clinitek novus and a 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: 7376928
• Report Number: 3002637618-2018-00040
• Device Sequence Number: 16459804
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: 00630414981147
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 10697937
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1