MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH CALCIUM_2 (CA_2)

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	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained erroneous calcium_2 (ca_2) results on two (2) patient samples on an atellica ch 930 analyzer for two patients.An erroneously elevated calcium_2 (ca_2) result for one patient sample was obtained on an atellica ch 930 analyzer.The erroneously elevated patient result was reported to the physician and questioned.The same sample was reprocessed on an alternate atellica ch 930 analyzer.A lower result was obtained, considered correct and reported to the physician.Erroneously depressed calcium_2 (ca_2) results for the other patient sample were obtained on an atellica ch 930 analyzer.The erroneously depressed patient results were reported to the physician and questioned.The same samples were reprocessed on an alternate atellica ch 930 analyzer.Higher results were obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed and elevated calcium_2 (ca_2) results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneous calcium_2 (ca_2) results on two (2) patient samples obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (10-jul-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer and the data from the instrument.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s laboratory ranges at the time of the event.Sos reviewed the calibration data for ca_2 on atellica ch 930 analyzer and observed variability for the c1 calibration coefficient across the different calibration events.The customer performed a new calibration prior to repeat testing which produced acceptable results.Based on the available information, the cause of the event maybe due to inconsistent reconstitution/handling of the calibrator material.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2025-00158 was filed on 18-jun-2025.

• Brand Name: ATELLICA CH CALCIUM_2 (CA_2)
• 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: 22286328
• Report Number: 2432235-2025-00158
• Device Sequence Number: 12980619
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)242373(17)251001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083386
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 10/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097644
• Device Lot Number: 242373
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 10/23/2024
• 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