MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH 930 CALCIUM_2 (CA_2); AZO DYE, CALCIUM

Model Number	11097644
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) to report falsely elevated atellica ch 930 calcium_2 (ca_2) results.Quality control (qc) was out of range, which prompted the customer in investigate, recalibrate and retest patient samples, which identified the discordant results.The customer states they have adjusted their qc ranges to be closer to peer data.The interpretation of results section of the instructions for use (ifu) states, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.".
Event or Problem Description
A falsely elevated calcium_2 (ca_2) result was obtained on 2 different patient samples on the same day on the same atellica ch 930 analyzer, serial number (s/n): (b)(6).The initial results were reported to the physician(s).The samples were reprocessed on a different atellica ch 930 analyzer.The repeat results were lower and considered correct.There are no known reports of patient intervention or adverse health consequences due to the erroneous ca_2 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2023-00130 on 2023-05-30.Additional information - 2023-05-16 siemens completed investigation for a united states (us) customer observation of falsely elevated atellica ch 930 calcium_2 (ca_2) results.The investigation results are as follows: the quality control (qc) data for atellica ch 930 analyzer # cm00715 showed that for both level 1 (56721) and level 3 (56723) ca_2 qc processed using cal id13639 were biased high and outside the customer's expected ranges.The same qc was within expected ranges for the ca_2 lot 221851 when using another cal id (13897) indicating the issue was not related to ca_2 reagent lot 221851.The qc data for another atellica ch 930 analyzer # cm00721 showed that for both level 1 (56721) and level 3 (56723) ca_2 qc processed using cal id 7977 were biased high and outside the customer's expected ranges.The same qc was within expected ranges for the ca_2 lot 221851 when using another cal id (8206) indicating the issue was not related to ca_2 reagent lot 221851.Siemens reviewed the calibration data for atellica cm00715 and cm00721 and compared the mean ca_2 qc recovery across different calibration events (cal id).Siemens observed significant variability with the c1 (slope) calibration coefficient across different calibration events using chem cal lot 497936 and ca_2 reagent lot 221851 and 231884.The lower c1 (slope) mau (milli-absorbance unit) would adversely affect the calibration curve and is likely contributing to the higher ca_2 qc recovery and patient results when processed using the impacted calibration events (cal id).The variability in ca_2 qc recovery correspond to the variability observed with the ca_2 calibrations suggesting the issue may potentially be related to inconsistent calibrator handling/reconstitution of the chem cal and not a specific lot of calibrator material, reagent lot, or the qc product.Inconsistent preparation and handling of the chem cal material can increase imprecision and impact recovery for both qc and patient results.Using incorrect pipettes, inadequate mixing, or failing to ensure homogeneity of the chem cal material are possible contributing factors.Based on the available, a product performance issue has not been identified.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH 930 CALCIUM_2 (CA_2)
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES, LTD.; 55 diamond road; registration # 8020890; crumlin co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17025969
• Report Number: 2432235-2023-00130
• Device Sequence Number: 14735074
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: 00630414220697
• Combination Product (Y/N): N
• 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): Unknown
• 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): 07/09/2023

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: 12/01/2023
• Device Model Number: 11097644
• Device Catalogue Number: 11097644
• Device Lot Number: 221851
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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