MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK NOVUS

Catalog Number	10697937
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation into the customer's issue was found to be attributed to user error.The customer stored their novus cassettes in the refrigerator for over a week.Per the novus cassette ifu: store the unopened cassette at room temperature at 15¿30°c and ensure that humidity does not exceed 80%.Do not store in a refrigerator.Improperly stored reagent should be discarded, and the test should be repeated with properly handled reagent.
Event or Problem Description
The customer alleged an issue with the clinitek novus verses the atellica uas 800 after installation where the novus was giving less leukocytes (leu) than white blood cells (wbc).The cassette was calibrated again but keeps giving less leu than it should.The microscopic pictures show that the atellica uas 800 is measuring the particle well, but it does not in any way meet the measurements in the novus.The escalation was opened against the clinitek novus, but the customer does not know which analyzer's results are expected to be true.There was no report of harm due to this event.

• Brand Name: CLINITEK NOVUS
• Common Device Name: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 19809967
• Report Number: 3002637618-2024-00077
• Device Sequence Number: 8303424
• Product Code: KQO
• UDI-Device Identifier: 00630414981147
• UDI-Public: (01)00630414981147
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K140717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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: 10697937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown