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

Catalog Number	SMN 11097595
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed calcium (ca) patient sample result obtained on an atellica ® ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed calcium (ca) patient sample result was obtained on an atellica ® ch 930 analyzer.The falsely depressed patient result was reported to the physician and was not questioned.The same sample was reprocessed on an alternate atellica ® ch 930 analyzer.The higher reprocessed result obtained was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed calcium (ca) patient result.
Additional Manufacturer Narrative
Additional information (12-jan-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument data logs.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed maintenance that was part of standard troubleshooting, including changing the reagent lot.Hsc notes that quality control (qc) was out-of-range when processed using two different reagent packs/wells of calcium (ca) with the same calibrator lot#10797, indicating that the issue was not related to the specific reagent pack/well, rather related to the calibrator lot.Calcium qc processed using the same reagent packs/wells, but a different calibrator lot were consistently within the 2 standard deviation (2sd) peer range.Hsc observed variability with the calibration coefficients across calibration events which suggests inconsistent reconstitution/handling of the atellica chemistry calibrator (chem cal) material.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h3 and h6 have been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00001 was filed on 05-jan-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): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18453604
• Report Number: 2432235-2024-00001
• Device Sequence Number: 12708000
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: 00630414595672
• Combination Product (Y/N): N
• 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): 02/06/2024

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: 06/01/2024
• Device Catalogue Number: SMN 11097595
• Device Lot Number: 231931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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