MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH CALCIUM (CA)

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens one (1) calcium (ca) discordant patient sample result was obtained when processed twice on an atellica ch 930 analyzer.It is unknown which of the results is correct or if any of the results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant calcium (ca) patient sample result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding one (1) calcium (ca) discordant patient sample result obtained when processed twice on an atellica ch 930 analyzer.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (26-aug-2025): the instrument was not serviced by a third party.Section d8 was updated with the information.Initial mdr 2432235-2025-00224 was filed on 26-aug-2025.
Additional Manufacturer Narrative
Additional information (01-dec-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Quality control (qc) recovered within the customer¿s expected ranges, indicating the calcium (ca) assay was performing acceptably.Sos reviewed the calibration data for ca and observed the initial and repeat result were processed using different calibration events.The calibration data showed that the calibration used to process the sample initially had a higher c1 calibration coefficient and signal response when compared to other calibration events using the same reagent.Siemens concluded the cause of the erroneous result was the calibration used to process the affected sample.The issue was resolved by recalibrating the ca assay using the same reagent lot, which was part of standard troubleshooting procedures.The cause of the calibration differences cannot be determined.The customer is operational.A potential product issue was not identified.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2432235-2025-00224 was filed on 26-aug-2025.Mdr 2432235-2025-00224 supplemental report 1 was filed on 19-sep-2025.

• Brand Name: ATELLICA CH CALCIUM (CA)
• Common Device Name: CALCIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES LTD; 55 diamond road; registration # 8020890; crumlin, county antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 22897839
• Report Number: 2432235-2025-00224
• Device Sequence Number: 8958135
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: (01)00630414595672(10)252470(17)260401
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K991576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097595
• Device Lot Number: 252470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 12/01/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/19/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2024
• 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