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	07/10/2018
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.The customer states they run qc daily and the results are in the expected range.Proper maintenance was reviewed with the customer and a new fixed platform was sent to the customer.The customer bulletin on leukocytes was reviewed with the customer regarding higher specific gravity.The customer stated that the patient results that he did review, most had higher specific gravity.The cause of this event is unknown.
Event or Problem Description
The customer reported (b)(6) leukocytes in urine on two patients tested on the clinitek advantus when compared to the microscopic reading of the sediment.There was no report of injury due to this event.

• Brand Name: CLINITEK ADVANTUS
• Common Device Name: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7731692
• Report Number: 3002637618-2018-00086
• Device Sequence Number: 2541573
• Product Code: JIL
• UDI-Device Identifier: 00630414593562
• UDI-Public: 00630414593562
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1