MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM BR 27.29 (BR); 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 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from the united states obtained a falsely elevated br 27.29 (br) patient sample result on atellica im analyzer.The initial result was reported to the physician(s), who questioned the result.The same sample was measured on an alternate testing method (advia centaur) and the result was lower compared to the atellica im result.The interpretation of results section of the atellica im br 27.29 (br) 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." siemens healthcare diagnostics is investigating.

Event Description

The customer obtained a falsely elevated br 27.29 (br) patient sample result on atellica im analyzer.The initial result was reported to the physician(s), who questioned the result.The same sample was measured on an alternate testing method (advia centaur) and the result was lower compared to the atellica im result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated br 27.29 (br) result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00183 on 05-sep-2023.Additional information 24-jan-2024: a customer from the united states obtained a falsely elevated br 27.29 (br) patient sample result (55.06 u/ml) on atellica im analyzer.The initial result was reported to the physician(s), who questioned the result.The same sample was measured on an alternate testing method (advia centaur) and the result (34 u/ml) was lower compared to the atellica im result.Reviewing the data, siemens identified that the lot calibration used to generate the 55.06 u/ml result with sample 58596460 had not been verified with quality control (qc) in over a week.The qc that recovered acceptably prior to sample 58596460 used a different pack calibration but the 55.06 u/ml result was not generated with that pack.When the pack with the pack calibration used for qc was used up, the analyzer switched to using a different pack which did not have a pack calibration, so the analyzer defaulted to the lot calibration that was used to generate the 55.06 u/ml result.The qc the customer ran with the lot calibration after sample 58596460 was tested recovered high so the customer recalibrated.Siemens reviewed the calibrations and observed differences in relative light units (rlus).Siemens performed an offline calculation using the sample 58596460 relative light units with the new calibration and showed the sample 58596460 result would have been 34 u/ml if the br pack had been calibrated before testing the sample.Based on the available information, the cause of the difference in calibrator rlus between the lot calibration and the new calibration could not be determined but siemens cannot rule out reagent shipping/handling.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• Type of Device: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17682479
• MDR Text Key: 322626114
• Report Number: 1219913-2023-00183
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414598055
• UDI-Public: 00630414598055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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: 03/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 269
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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