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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

The customer reports observation of a falsely depressed calcium result on an atellica ch 930 analyzer, when using reagent lot 221818.The initial result was reported to the physician(s) who questioned the result.The sample was repeated on new reagent pack and higher result was obtained.There are no known reports of patient interventions or adverse health consequences due to the erroneous calcium result.

Manufacturer Narrative

An outside of the united states (ous) customer reports observation of a falsely depressed calcium result on an atellica ch 930 analyzer (b)(6), when using reagent lot 221818.The initial result was reported to the physician(s) who questioned the result.The sample was repeated on new reagent pack and higher result was obtained.The customer obtained a discrepant patient result with the atellica ch calcium method using an atellica ch 930 (b)(6).The original sample was repeated using the original instrument.The repeat result was used to issue a corrected report.Repeat of the same sample yielded the expected results.The return of the patient sample was not required or warranted based upon the results of the technical evaluation.Siemens reviewed the calibration data for cm00670 and observed that ca lot 221818 was placed into use on 06/29/2023.The customer had processed multiple packs/wells of reagent lot 221818 without issue until 08/16/2023 when the customer observed low recovery for the ca patient results using pack 14011/well 2.The customer loaded pack 14011 on 08/14/2023.Quality control (qc) was processed using this ca reagent pack/well was processed at 10:51 on 08/14/2023 when the pack was placed into use.The ca quality control (qc) recovery was acceptable and within a 2sd peer range (customer range not provided).The customer continued to use pack 14011/well 1 until 08/16/2023 at 15:23, when the instrument switched to well 2 of the same reagent pack on 08/16/2023 at 15:23.The patient sample was processed using pack 14011/well 2 prior to quality control (qc) being processed on 08/16/2023 at 17:35.Both level 1 (89711) and level 2 (89712) showed significantly low recovery and were outside of a 2sd peer range.The customer removed pack 14011 and no additional patient samples or quality control (qc) were processed using pack 14011/well 2.On 08/16/2023 at 18:32, the customer loaded a new reagent pack (14045), and calibrated ca.Quality control (qc) was processed after the calibration for the new pack 14045/well 1 and all results were within a 2sd peer range.The data showed the customer continued to process samples on 08/16/2023 using the new pack 1405/well 1 with no additional ca issues.The customer contained to use multiple a new ca reagent lot 231883.The customer inspected reagent pack 14011 after it was removed from the instrument and observed that well 2 appeared to be tinted yellow.When pack 14011/well 2 was compared to other ca reagent packs, the reagent was clear and not yellow.The customer provided a picture of the discolored reagent well.No other ca reagent packs for lot 221818 were impacted.The issue was isolated to a single well (well 2) of ca reagent pack 14011.Based on the information provided, siemens concludes the probable cause of the low discrepant ca patient results and out of range quality control (qc) was due to an issue with a single ca reagent well from one reagent pack of ca lot 221818.However, there is insufficient information available to identify what caused the single well of one ca reagent pack lot 221818 to be compromised/contaminated.No other packs/wells from ca lot 221818 were impacted.The issue was isolated to well 2 of a single ca reagent pack.The customer resolved the issue by replacing the affected ca reagent pack, calibrating, and processing quality control (qc).The customer continued to process samples using multiple packs/well of ca reagent lot 221818 with no further ca issues.The actions taken by the customer are part of normal troubleshooting for issues of this nature.The interpretation of results section of the atellica ch calcium instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the customer is currently fully operational.

• Brand Name: ATELLICA CH CALCIUM_2 (CA_2)
• Type of Device: CRESOLPHTHALEIN COMPLEXONE, CALCIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; registration # 8020890; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17746417
• MDR Text Key: 323417633
• Report Number: 1219913-2023-00192
• Device Sequence Number: 1
• Product Code: CIC
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K991576
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 11097595
• Device Lot Number: 221818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Date Device Manufactured: 10/01/2022
• 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