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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely depressed calcium_2 (ca_2) result on a female patient sample on atellica ch analyzer.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on an alternate atellica ch analyzer, and the result was higher than the initial result.The repeat result was considered as correct, and a corrected report was provided.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca_2 result.
Additional Manufacturer Narrative
A customer from the united states observed a falsely depressed calcium_2 (ca_2) result on a female patient sample on atellica ch analyzer.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on an alternate atellica ch analyzer and the result was higher than the initial result.The repeat result was considered as correct, and a corrected report was provided.The interpretation of results section of the atellica ch ca_2 instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the limitations section of the atellica ch ca_2 instructions for use (ifu) states: "the atellica ch ca_2 assay is limited to the detection of calcium in human serum, plasma (lithium heparin) and urine." siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00184 on sep 05, 2023.Additional information sep 13, 2023 and sep 19, 2023: the customer observed a falsely depressed calcium_2 (ca_2) result on a female patient sample on atellica ch analyzer.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on an alternate atellica ch analyzer, and the result was higher than the initial result.The repeat result was considered as correct, and a corrected report was provided.Return of the patient sample was not required or warranted based upon the results of the technical evaluation.A review of the ca_2 quality control (qc) showed consistent recovery within the customer's expected ranges.The instrument data showed that ca_2 reagent lot 231932 was initially calibrated with a lot calibration (cal id 10693) on (b)(6) 2023 at 03:31.The customer processed the sample and qc using this reagent lot without issue until (b)(6) 2023 when the sample in question was identified.On (b)(6) 2023, the customer loaded a new reagent pack (pack 14055) of ca_2 lot 231932.Qc was processed at the time the pack was loaded on the instrument.Level 1 (92941) and level 2 (92942) was processed using pack 14055/well 1 and the lot calibration (cal id 10693) from (b)(6) 2023 at 03:31.Both levels of qc were within the customer's expected ranges indicating the issue was not related to ca_2 pack 14055/well 1.The ca_2 result in question that was identified by the customer was processed using ca_2 reagent pack 14055, well 1 and the lot calibration (cal id (b)(6)) from (b)(6) 2023 at 03:31.The instrument data showed that the sample in question was with no issues in ca_2 recovery.Further supporting, the issue was not due to ca_2 reagent lot 231932 or a specific reagent pack/well.To verify instrument performance, the customer ran a ca_2 linearity, multiple ca_2 precision studies, and a patient correlation.All linearity and precision results were acceptable.The patient comparison study also showed acceptable recovery differences with an average ca_2 difference of 0.15 mg/dl or 1.7%.The customer continued to process samples and qc using multiple packs/wells of ca_2 lot 231932 with no further ca_2 issues.Recovery issues.No additional troubleshooting was performed, and no customer service engineer (cse) was dispatched.Based on the information provided, siemens is unable to conclusively determine the probable cause of the discrepant ca_2 patient result.All ca_2 qc showed consistent recovery within expected ranges.The customer verified instrument performance by running a ca_2 linearity, multiple precision studies, and patient comparisons.All results were acceptable indicating the issue was not due to ca_2 reagent lot 231932 or a specific reagent pack/well.The customer continued to process the sample with no further ca_2 issues.The actions taken by the customer were part of normal troubleshooting/maintenance for issues of this nature.The customer is fully operational.

• Brand Name: ATELLICA CH CALCIUM_2 (CA_2)
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17682549
• Report Number: 1219913-2023-00184
• Device Sequence Number: 19485138
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: 00630414220697
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 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): 10/09/2023

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: 03/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097644
• Device Lot Number: 231932
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: 63 YR
• Patient Sex: Female