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

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	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding an erroneously depressed calcium_2 (ca_2) result obtained on a patient sample on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that an erroneously depressed calcium_2 (ca_2) result was obtained on a patient sample on an atellica ch 930 analyzer.The initial result was not reported to the physician.The same sample was reprocessed on the same atellica ch 930 analyzer.The reprocessed result recovered higher than the initial result and was reported as correct result to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed ca_2 result.
Additional Manufacturer Narrative
Additional information (30-jan-2025): siemens concluded the investigation of the event.Siemens reviewed the instrument data files and the information provided by the customer.The review of calibration data showed that the customer used a bad/atypical calibration lot, which yielded atypical calibration coefficients, atypical calibrator signal response, and unacceptable quality control (qc) results.Siemens observed that an erroneous depressed result was obtained using atypical calibration.Recalibration of the assay was performed by the customer using the other calibration and qc recovery was within the customer¿s expected ranges.Siemens concluded that the cause of the event was consistent with the use of a bad/atypical lot calibration.The issue was resolved by recalibrating the calcium_2 (ca_2) assay, which was part of standard troubleshooting procedures.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2432235-2025-00005 was filed on 03-jan-2025.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CALCIUM_2 (CA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; crumlin, co. antrim; registration # 8020890 BT29 4QY; UK BT29 4QY
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21065995
• Report Number: 2432235-2025-00005
• Device Sequence Number: 19653056
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)242276(17)250601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 06/01/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097644
• Device Lot Number: 242276
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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