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

Catalog Number	SMN 11097595
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained erroneously elevated calcium (ca) results on two (2) patient samples on an atellica ch 930 analyzer.The erroneous results were not reported to the physician.The same samples were reprocessed on the same atellica ch 930 analyzer.The lower reprocessed results obtained were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated calcium (ca) results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated calcium (ca) results obtained on two (2) patient samples on an atellica ch 930 analyzer.Siemens is evaluating the event.
Additional Manufacturer Narrative
Additional information (17-jan-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Quality control (qc) recovered low and outside the customer¿s expected ranges when processed using specific calibration but recovered within customer's expected ranges when processed using other calibrations with the same calibrator lots, indicating that the calcium (ca) assay and calibrator lots were performing acceptably.Siemens reviewed the calibration data and observed that for a specific calibration, the calibration coefficient was significantly higher when compared to other calibrations.The cause of the event was consistent with an issue specific to the lot calibration.Investigation of the event is consistent with the calibration issue which could have been caused by inconsistent reconstitution or handling of the calibrator material.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 2432235-2024-00334 was filed on 05-dec-2024.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CALCIUM (CA)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim 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: 20851503
• Report Number: 2432235-2024-00334
• Device Sequence Number: 14435595
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: (01)00630414595672(10)242226(17)250601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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 Catalogue Number: SMN 11097595
• Device Lot Number: 242226
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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