MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS

Catalog Number 10309477

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer inspected the instrument and found that the pipette was bent.Siemens service went onsite and cleaned out the sample probe with water.He inspected the readhead and it was clean.The system was restarted and fresh controls were run.The system was fully functional on departure.

Event Description

The customer reported a false negative urine leukocyte result on the clinitek atlas when compared to a visual read of the multistix 10 sg, a microscopic analysis of the sediment and a uf 1000i analyzer.There was no report of injury due to this event.

• Brand Name: CLINITEK ATLAS
• Type of Device: CLINITEK ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SPARTAN MEDICAL; 22740 lunn road; cleveland OH 44149
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 9372442
• MDR Text Key: 169087372
• Report Number: 3002637618-2019-00125
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932674
• 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: 11/25/2019

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: 10309477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/25/2019
• 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