MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS

Catalog Number	10309477
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens received an update from the complaint preparer indicating that the customer was operational after service intervention.The engineer replaced the pipette assembly, lamp, and the heat absorbing filter.The engineer also checked and cleaned the readhead assembly, retaining ring, and source optics.After service, the system was operational according to the customer and all qc recovered within range.Because the issue was resolved via troubleshooting and service intervention, further investigation into the root cause of the issue is not required.It should be noted that the customer identified the use of boric acid in some of the patient samples.Additionally, the customer stated that samples were left at room temperature for over 24 hours prior to analysis.Per the reagent ifu, urine should be analyzed soon after voiding and the use of a preservative is not recommended: "test the urine within two hours after voiding.If unable to test within the recommended time, refrigerate the specimen immediately and let it return to room temperature before testing.Work areas and specimen containers should always be free of detergents and other contaminating substances.Use of preservatives of any kind is not recommended, as they may affect test results.".
Event or Problem Description
The customer reported a false negative leukocyte result one patient and a false negative blood on another patient run on the clinitek atlas, when compared to a manual microscopic exam and an automated microscopic exam of the urine sediment.There was no report of injury due to this event.

• Brand Name: CLINITEK ATLAS
• Common Device Name: CLINITEK ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11327868
• Report Number: 3002637618-2021-00006
• Device Sequence Number: 13299160
• Product Code: KQO
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K932674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10309477
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1