MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens regional support center to report the observation of a false low eosinophil result obtained on an advia 560 hematology system.The initial result was flagged appropriately and was not reported to the physician(s).The customer performed a manual count on a stained smear, and the result was higher and reported as the correct result to the physician(s).Siemens healthineers reviewed the complaint and provided the following investigation summary: the original issue is reported as eosinophilia not detected by the advia 560.Siemens has reviewed the data provided and can see that the "e" flag is present which indicates that the analyzer could not clearly distinguish between the eos and neutrophil populations.In this case a manual slide should be made to accurately count the differential.A slide was made and the count was corrected.The result is specific to this patient sample, the quality control (qc) was within range, and the system is currently operational.The analyzer is performing according to specification, and no further evaluation of the device is required.
Event or Problem Description
The customer reported the observation of a false low eosinophil result obtained on an advia 560 hematology system.The result was appropriately flagged and the advia 560 hematology system operator's guide instructed the customer to perform a manual count on a stained smear.The customer performed the manual count, and the eosinophil result was higher.The higher eosinophil result from the manual count was considered to be the correct result and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the false low eosinophil result.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): DIATRON MI PIC; tablas str. 39; registration #: 3009297077; budapest H-109 7; HU H-1097
• Manufacturer Contact: jennifer cacace ; 511 benedict ave.; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 24500847
• Report Number: 2432235-2026-00067
• Device Sequence Number: 9960255
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: (01)00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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 Model Number: N/A
• Device Catalogue Number: 11170842
• Device Lot Number: N/A
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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