MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS

Catalog Number 10494134

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

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 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
• Type of Device: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 8622285388
• MDR Report Key: 8343552
• MDR Text Key: 137013118
• Report Number: 3002637618-2019-00018
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00630414981130
• UDI-Public: 00630414981130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 10494134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1