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

Catalog Number	SMN 11097644
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant elevated calcium_2 (ca_2) results obtained on multiple patient samples on an atellica ch 930 analyzer.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained discordant elevated calcium_2 (ca_2) results on multiple patient samples on an atellica ch 930 analyzer.The elevated results were reported to the physician and were questioned.The same samples were reprocessed on the original and an alternate atellica ch 930 analyzer and the results obtained were similar to the initial results.The customer did not provide any patient sample data.The correct results for the patients are unknown.There are no known reports of patient intervention or adverse health consequences due to the elevated calcium_2 (ca_2) results.
Additional Manufacturer Narrative
Additional information (13-nov-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges, indicating that the calcium_2 (ca_2) assay was performing acceptably.Hsc reviewed the precision studies performed and found no evidence of imprecision.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00292 was filed on 11-nov-2024.

• 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; registration # 8020890; 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: 20650217
• Report Number: 2432235-2024-00292
• Device Sequence Number: 8886044
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)232088(17)241101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• 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): 12/05/2024

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: 11/01/2024
• Device Catalogue Number: SMN 11097644
• Device Lot Number: 232088
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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