MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS

Catalog Number 10309477

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated they inspected the reagent roll, the installation of the roll, the pipettor for damage and the take up reel and all appeared to be in good condition.The cse worked with the manager and she replaced the light bulb on the system, inspected the readheads and found they were clean.He had her flush the rinse bottle with bleach and prime bleach through the probe.She thoroughly rinsed the bottle out and replaced the di water and rinse solution.During the troubleshooting she replaced the reagent roll with a different lot number than the one that was installed.The system has passed calibration multiple times with no issues.The qc has been run multiple times throughout the day with no issues.They have been monitoring the system and there have been no further instances or discrepancies.The system is online and fully functional.The customer no longer has the reagent roll to send back for investigation.The customer was also unable to verify the true color/clarify of the first sample, nor could the customer verify that it wasn't spun prior to the second analysis.Without the product being returned for investigation, or verification from the customer that the integrity of the sample was not compromised prior to analysis, the root cause cannot be determined.The certificate of analysis was reviewed for lot 1a159120 and the lot met performance specifications prior to manufacturing release.Complaint data is not showing any trend related to this lot.

Event Description

The customer reported two patients that had false negative results on the clinitek atlas when compared to the clinitek status and microscopic exam of the urine sediment.Patient #1 had false negatives for leucocytes and patient #2 had a false negative for blood.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: 11440569
• MDR Text Key: 243090608
• Report Number: 3002637618-2021-00013
• 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: 03/08/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/08/2021
• 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