MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2); ENZYMATIC METHOD, BILIRUBIN

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer obtained a falsely depressed total bilirubin_2 (tbil_2) result on a newborn child patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original atellica ch instrument and again repeated on an alternate atellica ch instrument.The repeat results recovered higher than the erroneous result.The repeat results were reported as the correct result to the physician(s).The interpretation of results section of the atellica ch total bilirubin_2 (tbil_2) 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 depressed total bilirubin_2 (tbil_2) result on a newborn child patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original atellica ch instrument and again repeated on an alternate atellica ch instrument.The repeat results recovered higher than the erroneous result.The repeat results were reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous tbil_2 result.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00180 on jun 23, 2023.Additional information - jun 27, 2023 and jun 28, 2023: an outside the united states customer obtained a falsely depressed total bilirubin_2 (tbil_2) result on a newborn child patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original atellica ch instrument and again repeated on an alternate atellica ch instrument.The repeat results recovered higher than the erroneous result.The repeat results were reported as the correct result to the physician(s).After performing investigation on atellica ch and dms aptio, the customer confirmed that the first sampling has been performed on a urine sample (large tube) with a serum label on it, so mislabeled.The second result (correct result) was generated on a small tube which was serum.Based on siemens review of additional information, the probable cause of assay range flagged for total bilirubin_2 (tbil_2) results for the initial run of sample id (b)(6) is most likely due to operator error by running a urine sample incorrectly labeled as serum with sample id (b)(6).The instrument is fully operational.Correction: in section d9 - device returned to manufacturer? was checked in error in the initial mdr.In section b6, patient sample id (b)(6) added was incorrect.The correct sample id is (b)(6).In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
• Type of Device: ENZYMATIC METHOD, BILIRUBIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive; newark DE 19714 6101
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17189476
• MDR Text Key: 317728529
• Report Number: 2432235-2023-00180
• Device Sequence Number: 1
• Product Code: JFM
• UDI-Device Identifier: 00630414595818
• UDI-Public: 00630414595818
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K170065
• 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: 07/17/2023

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: 03/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097531
• Device Lot Number: 123517
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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