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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

Falsely elevated calcium_2 (ca_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The results were reported to the physician(s), who questioned the results.The samples were repeated on alternate atellica ch 930 analyzers.The repeat results were lower than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca_2 results.

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center to report discordant (elevated) atellica ch 930 (analyzer # (b)(4)) calcium_2 (ca_2) (lot 231884) results on multiple patient samples.Quality control (qc) was found to be out of range which led to the retest of patient samples and identification of discordant initial results.The original samples were repeated using alternate atellica ch 930 analyzers and results were lower and considered correct.Return of the patient samples was not required or warranted based upon the results of the technical evaluation.A review of the customer's ca_2 quality control (qc) showed that qc was consistently in expected ranges until (b)(6) 2023, when the customer observed out of range recovery.The qc was processed using ca_2 reagent lot 231884, pack 11281, well 1.A review of the instrument data for the samples in question showed all samples were processed using the same reagent pack/well as the out-of-range ca_2 qc.Siemens reviewed the instrument data for cm02649 and observed the customer had been using ca_2 lot 231884 with no issues since (b)(6) 2023.On (b)(6) 2023, the customer began using ca_2 reagent pack 11281, well 1.Qc was not configured to run when the instrument switched to a new pack.As a result, the customer processed patient samples from 08:24-14:00 on (b)(6) 202,3 using pack 11281, well 1, until ca_2 qc was processed at 14:00.Once the qc was processed, the recovery was elevated and outside of expected ranges.Siemens reviewed the ca_2 calibration data and no issues were identified related to the ca_2 calibration used to process the samples in question or out of range qc.Siemens reviewed the r1 check (reagent blank) for pack 11281, well 1 and observed elevated mau readings (approximately 175-185 mau).All other ca_2 reagent pack/wells for ca_2 lot 231884 showed lower mau readings (approximately 127-135 mau).The higher r1 check was not observed for any other pack/well used for processing qc or patient samples.The issue was isolated to pack 11281, well 1.The impacted reagent pack (11281) was discarded by the customer so no further testing can be performed to determine the probable cause of the issue.The customer replaced and discarded ca_2 pack 11281 and replaced it with a new pack from the same lot (231884).The customer recalibrated ca_2 and ran qc.All qc results were within expected ranges.The customer has continued to use ca_2 reagent lot 231884 with no further ca_2 issues.Multiple ca_2 packs have been used to process patient samples since pack 11281 was removed with no further recovery issues.The issue was isolated to a single ca_2 reagent pack/well for ca_2 reagent lot 231884.The customer stated that a siemens customer service engineer (cse) was dispatched but no service was performed on the instrument as replacing the reagent pack and recalibrating ca_2 resolved the issue.Based on the information provided, the probable cause of the discrepant patient results and out of range qc was due to an issue with a single ca_2 reagent pack/well from ca_2 lot 231884.The affected ca_2 reagent pack was discarded by the customer, so further testing cannot be performed to determine what caused the specific ca_2 reagent pack to be compromised/contaminated.The issue was resolved with routine troubleshooting.The customer replaced the affected reagent pack with a new pack for the same ca_2 lot number.No other packs/wells from ca_2 lot 231884 were impacted.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." a product performance issue has not been identified.The customer is operational.

• Brand Name: ATELLICA CH 930 CALCIUM_2 (CA_2)
• Type of Device: AZO DYE, CALCIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; crumlin co. antrim; registration # 8020890 BT29 4QY; UK BT29 4QY
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17096959
• MDR Text Key: 316854167
• Report Number: 2432235-2023-00144
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: 00630414220697
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097644
• Device Lot Number: 231884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/09/2023
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1