MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH DIAZO TOTAL BILIRUBIN (D_TBIL); DIAZO COLORIMETRY, BILIRUBIN

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained three (3) erroneously depressed diazo total bilirubin (d_tbil) patient sample results on an atellica ch 930 analyzer.The erroneous results were not reported to the physician(s).The same samples were reprocessed on an alternate atellica ch 930 analyzer.Higher results were obtained, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed diazo total bilirubin (d_tbil) results.
Additional Manufacturer Narrative
An outside united states customer contacted the siemens healthcare diagnostics remote service center (rsc) regarding erroneously depressed diazo total bilirubin (d_tbil) results obtained on (3) three patient samples on the atellica ch 930 analyzer.Siemens healthcare diagnostics is investigating the event.
Additional Manufacturer Narrative
Additional information (26-jun-2025): siemens healthineers has confirmed, through complaint investigation, that the lot calibration claim of 90 days per the instructions for use may not be met when using the atellica ch d_tbil assay due to insufficient reagent 2 (p2) light protection.Siemens investigation indicated that light exposure of the reagent could have potentially led to the depressed results.An urgent field safety notice was issued to customers outside the us who may have purchased this product.A communication was not required within the united states as this product is not commercialized in the us.A design change will be performed to change the product packaging to opaque, black packs to address light sensitivity.In section h6, the investigation finding, and investigation conclusion codes were updated.Initial mdr 2432235-2025-00071 was filed on 19-mar-2025.

• Brand Name: ATELLICA CH DIAZO TOTAL BILIRUBIN (D_TBIL)
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 21468524
• Report Number: 2432235-2025-00071
• Device Sequence Number: 8750388
• Product Code: CIG
• UDI-Device Identifier: 00630414614922
• UDI-Public: (01)00630414614922(10)130471(17)250303
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K222104
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 03/03/2025
• Device Model Number: N/A
• Device Catalogue Number: 11537220
• Device Lot Number: 130471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown