MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 15-3 (CA 15-3); SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 11/12/2022

Event Type  malfunction  

Event Description

The customer reports observation of an elevated atellica im ca 15-3 result which was discordant relative to patient history.The customer obtained an elevated atellica im ca 15-3 result for a 33-year-old female patient which was considered inconsistent with patient history, and not reported to the physician.The result was considered falsely elevated, as the same patient sample had previously produced a lower result when tested earlier using the same method.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.

Manufacturer Narrative

A customer from outside the united states reports observation of an elevated atellica im ca 15-3 result for a 33-year-old female patient which was considered discordant relative to a lower result obtained earlier.The sample was originally tested on 2022-10-29 and was re-tested on 2022-11-05 as part of a retrospective review of test results following a quality control (qc) failure observation (high results) on 2022-11-10.It is noted that different calibrator lots had been used for the two tests.No qc excursions were reported in assocation with the discordant observation.The assay's instructions for use (ifu) advises the following, under limitations: "measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." siemens is investigating.

Manufacturer Narrative

Mdr 1219913-2022-00408 was initially filed on 2022-11-30.Additional information, 2022-12-29: siemens has concluded the investigation.A customer from outside the united states reported observation of an elevated atellica im ca 15-3 result which was inconsistent with patient history following a change to a new ca 15-3 calibrator.Review of quality control (qc) data showed a similar shift in results.The observed issue was resolved locally by recalibration of the assay.Siemens' review of customer data showed changes in assay signal level indicative of an issue with the customer's ca 15-3 reagents.It was noted that the storage refrigerator has an internal light, which may represent a cause for reagent degradation.The customer was appropriately advised.A review of internal data indicates that atellica im ca 15-3 kit lot 204 and calibrator lot c4370 were performing as intended.The cause of the discordant result could not be definitively identified, but reagent handling cannot be ruled out as a potential cause.Based on the investigation, no product problem was identified.The customer is operational, and no further support is needed.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM CA 15-3 (CA 15-3)
• Type of Device: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15890941
• MDR Text Key: 307687537
• Report Number: 1219913-2022-00408
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414598130
• UDI-Public: 00630414598130
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012357
• 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,Followup
• Report Date: 01/10/2023

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: 02/18/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995486
• Device Lot Number: 204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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
• Patient Age: 33 YR
• Patient Sex: Female