MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)

Model Number	N/A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that two patient samples tested for enzymatic hemoglobin a1c (a1c_e) on an atellica ch 930 analyzer generated error messages indicating the results were less than the measuring interval.However, results of >14.0% were transmitted to the laboratory information system (lis).Calibration and quality control (qc) were acceptable on the day of the event.On the subsequent day, the customer recalibrated.If a measuring interval flag appears on either the a1c or total hemoglobin (hb) component, no numeric a1c result can be reported.When the flag occurs, remix and rerun the sample.If it repeats, send the sample for testing by another method.However, the customer reported the initial results to the physician(s).Siemens reviewed the instrument files and observed that several error flags were sent to the lis for both the samples and confirmed that no numeric values were sent.Siemens further evaluated that event and determined that an operator error potentially contributed to the two patients a1c_e results being incorrectly reported as >14.0 %.The instrument and the atellica data management system (adm) reported correct information.The analyzer is performing according to specifications.No further evaluation is required.
Event or Problem Description
The customer reported that two patient samples tested for enzymatic hemoglobin a1c (a1c_e) on an atellica ch 930 analyzer generated error messages indicating the results were less than the measuring interval.However, results of >14.0% were transmitted to the laboratory information system (lis) and subsequently reported to the physicians, who questioned the results.Both samples were reprocessed multiple times on the original analyzer for troubleshooting purposes.All repeat results recovered less than measuring interval, yet the lis continued to display >14.0%.The expected results for these two samples were <3.8%.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24386398
• Report Number: 2432235-2026-00056
• Device Sequence Number: 10257676
• Product Code: PDJ
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150445(17)260915
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K200256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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 Expiration Date: 09/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097536
• Device Lot Number: 150445
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown