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

Model Number ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)

Device Problem Low Test Results (2458)

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

Event Date 09/29/2021

Event Type  malfunction  

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 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)
• Type of Device: ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration # 2517506; 500 gbc drive, po box 6101; newark DE 19714 6101
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 12675137
• MDR Text Key: 278118401
• Report Number: 2432235-2021-00261
• Device Sequence Number: 1
• Product Code: JFM
• UDI-Device Identifier: 00630414595818
• UDI-Public: 00630414595818
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K170065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR