MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)

Model Number	ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered low and out of range for a single reagent pack well.The operator recalibrated the affected reagent pack well, after which qc recovered in range.Patient results were not reported on this pack only quality control samples were run.When the remaining tests in the affected pack well were exhausted, the system automatically moved to the second well of the reagent pack and also into a new reagent pack.Qc shifted high based on the calibration coefficients from the previous calibration using the affected pack well for both the second well of the sample pack and the new pack, indicating the second well of the same pack was not contaminated.The operator recalibrated using the new reagent pack and obtained acceptable qc results.No issues with other reagent pack wells were observed.The cause of the event is a contaminated reagent pack well.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low total bilirubin_2 (tbil_2) result was obtained on a patient sample on an atellica ch 930 analyzer using atellica ch total bilirubin_2 reagent.The discordant result was not reported to the physician(s).The sample was repeated for tbil_2 on an alternate atellica ch 930 analyzer also using total bilirubin_2 reagent, recovering higher.The higher result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low tbil_2 result.

• Brand Name: ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
• Common Device Name: ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 12675137
• Report Number: 2432235-2021-00261
• Device Sequence Number: 4162068
• Product Code: JFM
• UDI-Device Identifier: 00630414595818
• UDI-Public: 00630414595818
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K170065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 06/20/2022
• Device Model Number: ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
• Device Catalogue Number: 11097531
• Device Lot Number: 110094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR