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

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	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a discordant elevated calcium (ca) 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 they obtained a discordant elevated calcium (ca) result on a patient sample on an atellica ch 930 analyzer.The elevated result was reported to the physician(s), and the result was questioned.The customer stated that the sample was unavailable for repeat testing, and it is unknown whether any repeat or redraw testing was performed later.The correct result for this patient is unknown.There are no known reports of patient intervention or adverse health consequences due to the elevated calcium (ca) result.
Additional Manufacturer Narrative
Additional information (23-oct-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Quality control (qc) recovery showed a slight high bias but was within the expected ranges, indicating that the calcium (ca) assay was performing acceptably.A review of the calibration data showed significant variability with the signal responses across the different calibration events (cal id).The variability observed with the calibration signals was consistent with the ca qc bias observed by the customer.The affected patient sample was processed using calibration that showed a lower average signal response, resulting in an elevated patient sample result.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse performed maintenance as part of standard troubleshooting for issues of this nature, including the replacement of several analyzer parts.Hsc cannot determine whether the event was caused by an analyzer issue or a specific calibration issue.Also, hsc cannot rule out inconsistent reconstitution/handling as a contributing factor to the calibration variability.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 2432235-2024-00224 was filed on 09-oct-2024.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CALCIUM (CA)
• 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, county 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: 20405877
• Report Number: 2432235-2024-00224
• Device Sequence Number: 17707654
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: (01)00630414595672(10)232139(17)250201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/07/2024

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: 02/01/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097595
• Device Lot Number: 232139
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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 Age: 28 YR
• Patient Sex: Male