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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant elevated calcium_2 (ca_2) results obtained on samples from three patients on an atellica ch 930 analyzer when compared to the historical results.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported discordant elevated calcium_2 (ca_2) three patient sample results were obtained on an atellica ch 930 analyzer when compared to the historical results.The discordant results were reported to the physician(s), who questioned the results.The customer has not provided the repeat results for these patient samples.The correct results are unknown for these patients.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated calcium_2 (ca_2) results.
Additional Manufacturer Narrative
Additional information (20-sep-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.A customer service engineer (cse) inspected the instrument and performed standard troubleshooting that included replacing the r1 probe, performing alignments and performing instrument maintenance (cleaning).Based on the information provided, hsc concludes the probable cause of the discrepant ca_2 results was due to instrument related issues.The actions taken by the cse were part of normal troubleshooting/maintenance for issues of this nature.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 was filed on 19-sep-2024.

• 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): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 20258602
• Report Number: 2432235-2024-00207
• Device Sequence Number: 20830028
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)242227(17)250401
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 04/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097644
• Device Lot Number: 242227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 04/22/2024
• 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