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	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated calcium (ca) patient sample result on an atellica ch (b)(4) analyzer.The erroneous patient result was reported to the physician and was questioned.The same sample was reprocessed on an alternate atellica ch (b)(4) analyzer.The lower 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 erroneously elevated calcium (ca) result.
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated calcium (ca) patient sample result obtained on an atellica ch (b)(4) analyzer.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.Hsc reviewed the ca calibration data and observed that the c1 (slope) calibration coefficient for the lot calibration performed on 08-may-2024 was significantly lower than the other calibration performed using the same ca reagent and calibrator lots.Quality control (qc) processed with this calibration was significantly higher and outside of expected ranges.The customer performed a new lot calibration after qc failure using the same reagent pack well 1.Qc recovered within the customer's expected ranges.Hsc concluded the cause of the event is consistent with the calibration.The customer is fully operational.The device is performing according to specifications.No further evaluation is required.

• 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.; 55 diamond road; registration # 8020890; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19475982
• Report Number: 2432235-2024-00129
• Device Sequence Number: 4036102
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: 00630414595672
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 10/01/2024
• Device Catalogue Number: SMN 11097595
• Device Lot Number: 232038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: 49 YR
• Patient Sex: Male