MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS

Catalog Number 10309477

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens service went on-site and performed the following: visually inspected the instrument, cleaned and inspected the read head, replaced the lamp and the reagent roll.The calibration was successfully completed and all levels of qc were in the expected ranges.The customer stated that no further assistance is needed and has not provided any further information on the issue after several requests from siemens.

Event Description

The customer reported a false negative leukocyte on the clinitek atlas when compared to the uf1000i, manual dipstick and a manual microscopic which all gave positive leukocyte results.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: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 7803085
• MDR Text Key: 117849679
• Report Number: 3002637618-2018-00102
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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
• Date Manufacturer Received: 08/08/2018
• 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