MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 125II (CA 125II); CA 125II IMMUNOASSAY

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	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant low atellica im ca 125ii (ca 125ii) result.Siemens is investigating.The instruction for use (ifu) under the taking corrective action section states the following: "if the quality control results do not fall within the assigned values, do not report results.Perform corrective actions in accordance with established laboratory protocol." the instruction for use (ifu) under the interpretation of results section states the following: "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 discordant low atellica im ca 125ii (ca 125ii) result was obtained on a patient sample.The customer when performing a routine quality control (qc) check observed an out of range low qc result that required an assay recalibration to resolve.The customer performed repeated testing on the only patient sample that was run prior to the routine qc check.The patient sample when repeated resulted higher.The higher ca 125ii was reported as the corrected result to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, low atellica im ca 125ii result.
Additional Manufacturer Narrative
Siemens filed mdr initial report on 03-jun-2021 for a discordant, falsely low atellica im ca 125ii (ca 125ii) result obtained on a patient sample.04-oct-2021 additional information: siemens has completed the investigation.The customer originally ran the sample on 09-may-2021 with reagent lot 196 (readypack p01519610103552) which resulted low (58.4 u/l).The reagent lot had been last calibrated on 10-apr-2021.Quality control (qc) levels 1 and 2 when run a couple of hours after the discordant result were out of range low.The customer recalibrated reagent lot 196 using the same reagent readypack (p01519610103552) and qc was acceptable.The same patient sample resulted higher (87.6 u/ml) when repeated.The customer when troubleshooting the issue performed addition testing (12-may-2021) with the same patient sample, same reagent readypack (p01519610103552), resulting higher (88.5 u/ml).The same patient sample when run again on 12-may-2021 with a new reagent readypack resulted higher (132.2 u/ml).This sample when run was not within the instructions for use (ifu ) sample handling recommendations.All atellica im ca125ii results generated on this patient were all greater than 30.2 u/ml (ifu 97.5% upper limit of normal).Based on the information provided, the potential cause for the varying results on this patient's sample may be attributed to the recalibration performed on 09-may-2021 with reagent readypack p01519610103552.The atellica im ca 125ii assay has an increased sensitivity to light exposure.It was observed that atellica im ca 125ii reagent readypacks were not stored in the reagent kit boxes.Siemens cannot rule out an issue with the reagent readypack and potential light exposure as quality control (qc) was out of range low at the time of the observed issue.A precision study check was performed at the customer site on patient samples, qc, and master curve material and the results were within acceptable limits.A product performance issue was not observed.The customer is operational.The instructions for use (ifu) under the storage and stability section states the following: "store reagents in an upright position.Protect the product from heat and light sources." the assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.

• Brand Name: ATELLICA IM CA 125II (CA 125II)
• Common Device Name: CA 125II IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11930989
• Report Number: 1219913-2021-00335
• Device Sequence Number: 14410811
• Product Code: LTK
• UDI-Device Identifier: 00630414598086
• UDI-Public: 00630414598086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200199
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 05/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995481
• Device Lot Number: 196
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR