MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA® IM BR 27.29 (BR) ASSAY; BR IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated br 27.29 (br) result was generated on a patient sample on an atellica im 1300 analyzer.The quality controls were acceptable at the time of the event; however, the next day were out of range high.The customer removed the reagents, remixed them, calibrated the assay, and repeated the qc.The qc recovered acceptably.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse replaced reagent probe 1, performed sample probe tests, and ran three levels of qc, which were all acceptable.The customer set up a delta check for br.The ifu states in the interpretation of results section: "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

A falsely elevated br 27.29 (br) (assay for ca 27.29) result was generated on a patient sample on an atellica im 1300 analyzer.The initial result was reported to physician(s), who questioned the result.The sample was repeated on the same atellica im 1300 analyzer and resulted lower than the initial result.Additionally, the patient was redrawn and the sample was processed on the same atellica im 1300 analyzer and the result was lower than the initial sample result.The repeat result was reported to the physician(s), as the correct result.Both the repeat and redraw results corresponded to the patient's historical result.There are no known reports of patient intervention or adverse health consequences due to the discordant br result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00088 on april 18, 2023.A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated br 27.29 (br) result was generated on a patient sample on an atellica im 1300 analyzer.The quality controls were acceptable at the time of the event; however, the next day were out of range high.The customer removed the reagents, remixed them, calibrated the assay, and repeated the qc.The qc recovered acceptably.May 4, 2023 additional information: the customer service engineer (cse) replaced reagent probe 1, replaced reagent probe 1, which dispenses ancillary reagent for the atellica im br 27.29 assay, due to the water sputtering as it was being primed out of the drain.However, a review of reagent trace files did not show an issue with the delivery of ancillary reagent by reagent probe 1 for the patient sample.Therefore, reagent probe 1 does not appear to be the cause of the elevated result for the patient sample.As part of the investigation of the event smart remote services (srs) data was reviewed from the customer site.Two additional samples tested on the same day exhibited elevated results.The results are below: sample identifier (b)(6) initial result: 65.1 u/ml repeat result: 48.4 u/ml sample identifier (b)(6) initial result: 55.5 u/ml repeat result: 40.1 u/ml the customer observed solid phase banding issues with the reagent readypack ((b)(6)) used to do the initial testing.For the br 27.29 assay, solid phase accumulation can lead to high recovery.The customer's average qc recovery with biorad inteliq tumor marker control lot 94931t was 18.0 u/ml and with control lot 94932t was 75.9 u/ml when using kit lot 267 (31 points with each lot).The customer's qc recovery was high but in range on the day the patient samples were initially tested.The qc recovery with reagent readypack (b)(6) on (b)(6) 2023 was 24.0 and 86.6 u/ml and on (b)(6) 2023 was 24.8 and 86.9 u/ml.Although reagent readypack (b)(6) was also used to do the repeat testing, it had been removed and remixed on (b)(6) 2023 prior to the repeat testing, which would mitigate the impact of solid phase accumulation.The customer's qc recovery was closer to the customer's average on the day the patient samples were retested.The qc recovery with reagent readypack (b)(6) on (b)(6) 2023 was 17.6 and 78.4 u/ml.Based on the shift in qc recovery being less than the shift in recovery seen with some of the patient samples, while the solid phase particle accumulation at the top of the readypack may have contributed to the bias between the initial and retest results, it does not explain all of the bias.Siemens cannot rule out pre-analytical factors or a sample issue contributing to the bias as the repeat testing was not performed on the same day as the initial testing.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA® IM BR 27.29 (BR) ASSAY
• Type of Device: BR IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 16761912
• MDR Text Key: 313570550
• Report Number: 1219913-2023-00088
• 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: 05/26/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: 68 YR
• Patient Sex: Female