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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS Back to Search Results
Catalog Number 10697937
Medical Device Problem Code Non Reproducible Results (4029)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/22/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.Siemens has submitted a request for additional information to properly assess the issue, but to date, most of the responses have not been received.The cause of this event is unknown.
 
Event or Problem Description
The customer reported falsely depressed leukocytes on the clinitek novus when compared to the microscopic examination of the urine sediment.There was no report of injury due to this event.
 
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Brand Name
CLINITEK NOVUS
Common Device Name
CLINITEK NOVUS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
MDR Report Key8609857
Report Number3002637618-2019-00057
Device Sequence Number15564897
Product Code KQO
UDI-Device Identifier00630414981147
UDI-Public00630414981147
Combination Product (Y/N)N
Initial Reporter CountryGG
PMA/510(K) Number
K140717
Number of Events Summarized1
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) 05/14/2019
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 Number10697937
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/24/2019
Initial Report FDA Received Date05/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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